Devices and methods for collecting and analyzing fluid samples from the oral cavity

ABSTRACT

Devices for collecting a fluid sample from the oral cavity, the device including a mouthpiece that includes a chamber, the chamber including front and rear inner walls; and means for collecting the fluid sample from the oral cavity; and methods of collecting and analyzing samples of fluid from the oral cavity, including the steps of placing the device in the oral cavity, collecting the fluid sample and conducting an analysis of the fluid sample.

The present application is a divisional application claiming the benefitof U.S. patent application Ser. No. 13/188,018 filed Jul. 21, 2011,which also claims the benefit of U.S. provisional application 61/367,594filed on Jul. 26, 2010, the entirety of which application is herebyincorporated by reference herein as if fully set forth herein.

FIELD OF THE INVENTION

The present invention relates to devices and methods suitable forin-home use to collect fluid samples from the oral cavity for analysis.

BACKGROUND OF THE INVENTION

In addition to regular professional dental checkups, daily oral hygieneis generally recognized as an effective preventative measure against theonset, development, and/or exacerbation of periodontal disease,gingivitis and/or tooth decay. Unfortunately, however, even the mostmeticulous individuals dedicated to thorough brushing and flossingpractices often fail to reach, loosen and remove deep-gum and/or deepinter-dental food particulate, plaque or biofilm. Most individuals haveprofessional dental cleanings biannually to remove tarter deposits.

For many years products have been devised to facilitate the simple homecleaning of teeth, although as yet a single device which is simple touse and cleans all surfaces of a tooth and/or the gingival orsub-gingival areas simultaneously is not available. The conventionaltoothbrush is widely utilized, although it requires a significant inputof energy to be effective and, furthermore, a conventional toothbrushcannot adequately clean the inter-proximal areas of the teeth. Cleaningof the areas between teeth currently requires the use of floss, pick, orsome such other additional device apart from a toothbrush.

Electric toothbrushes have achieved significant popularity and, althoughthese reduce the energy input required to utilize a toothbrush, they arestill inadequate to ensure proper inter-proximal tooth cleaning. Oralirrigators are known to clean the inter-proximal area between teeth.However, such devices have a single jet which must be directed at theprecise inter-proximal area involved in order to remove debris. Thesewater pump type cleaners are therefore typically only of significantvalue in connection with teeth having braces thereupon which often traplarge particles of food. It will be appreciated that if both debris andplaque are to be removed from teeth, at present a combination of anumber of devices must be used, which is extremely time consuming andinconvenient.

In addition, in order for such practices and devices to be effective, ahigh level of consumer compliance with techniques and/or instructions isrequired. The user-to-user variation in time, cleaning/treating formula,technique, etc., will affect the cleaning of the teeth.

The present invention may ameliorate one or more of the above mentioneddisadvantages with existing oral hygiene apparatus and methods, or atleast provides the market with an alternative technology that isadvantageous over known technology, and also may be used to ameliorate adetrimental condition or to improve cosmetic appearance of the oralcavity. In addition, the invention provides diagnostic capabilitieswhereby devices according to the present invention collect samples offluid from the oral cavity for analysis with respect to certain aspectsas described herein below.

SUMMARY OF THE INVENTION

The present invention is directed to devices suitable for collectingsamples of a fluid from the oral cavity of a mammal, the deviceincluding a mouthpiece and means for collecting the fluid sample fromthe oral cavity. The mouthpiece includes a chamber defined by front andrear inner walls and a base inner wall of the mouthpiece, the base wallextending between the front and rear inner walls. The invention isfurther directed to methods of collecting and analyzing samples of fluidfrom the oral cavity, including the steps of placing the device in theoral cavity, collecting the fluid samples and conducting an analysis ofthe fluid samples thus collected.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic drawing of one embodiment of an apparatus that maybe utilized in the present invention;

FIG. 2 is a schematic drawing of an alternative embodiment of anapparatus that may be utilized in the present invention;

FIG. 3 is a schematic drawing of another alternative embodiment of anapparatus that may be utilized in the present invention;

FIG. 4a is a perspective drawing of an embodiment of a reciprocatingflow controller that may be utilized in the present invention;

FIG. 4b is an exploded view of the reciprocating flow controller of FIG.4 a;

FIG. 4c is a top view of the reciprocating flow controller of FIG. 4a inits first position;

FIG. 4d is a top view of the reciprocating flow controller of FIG. 4a inits second position;

FIG. 5 is a top front perspective view of a first embodiment of anapplication tray that may be utilized in the present invention;

FIG. 6 is a bottom rear perspective view of the embodiment of theapplication tray of FIG. 5;

FIG. 7 is a vertical sectional view of the application tray of FIG. 5;

FIG. 8 is a horizontal sectional view of the application tray of FIG. 5;

FIG. 9 is a top back perspective view of a second embodiment of anapplication tray that may be utilized in the present invention;

FIG. 10 is a top front perspective view of the embodiment of theapplication tray of FIG. 9;

FIG. 11 is a top view of the application tray of FIG. 9;

FIG. 12 is a cut-away view of the application tray of FIG. 9;

FIG. 13 is a top front perspective view of a third embodiment of anapplication tray that may be utilized in the present invention;

FIG. 14 is a top back view of the embodiment of the application tray ofFIG. 13;

FIG. 15 is a bottom back view of the embodiment of the application trayof FIG. 13;

FIG. 16 is a cut-away view of the application tray of FIG. 13;

FIG. 17a is an exploded view of an embodiment of a hand piece that maybe utilized in the present invention;

FIG. 17b is an exploded view of the pumping section of the hand piece ofFIG. 17 a;

FIG. 17c is an exploded view of the vacuum section of the hand piece ofFIG. 17 a;

FIG. 17d is a side view of the drive system of the pumping and drivingsections of the hand piece of FIG. 17 a;

FIG. 17e is a cut-away view of the hand piece of FIG. 17 a;

FIG. 18a is a front, top perspective view of an embodiment of a systemthat may be utilized in the present invention;

FIG. 18b is a front, top perspective view of the hand piece section ofthe system;

FIG. 18c is a front, top perspective view of the liquid reservoirsection of the system;

FIG. 18d is an inset view of a region of the liquid reservoir of FIG. 18c;

FIG. 18e is cross-sectional view of the hand piece section of thesystem;

FIG. 18f is an inset view of a region of the hand piece of FIG. 18 e;

FIG. 18g is a front, top perspective view of the system of FIG. 18a ,with the liquid reservoir attached to the base station;

FIG. 18h is an inset view of a region of base station of FIG. 18 g;

FIG. 18i is a cut-away view of the base station of the system of FIG. 18a;

FIG. 18j is a cut-away view of the system of FIG. 18a , with the liquidreservoir attached to the base station;

FIG. 18k is a cut-away view of the system of FIG. 18a , with the liquidreservoir and the hand piece attached to the base station; and

FIG. 18l is an inset view of a region of base station and hand piece ofFIG. 18 k.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to devices suitable for collectingsamples of a fluid from the oral cavity of a mammal. The device includesa mouthpiece comprising a chamber for fitting around the teeth of theuser and means for collecting the fluid sample from the oral cavity. Incertain embodiments, the mouthpiece is suitable for directing a liquidonto a plurality of surfaces of the oral cavity. In such embodiments,the chamber maintains the liquid proximate the plurality of surfaces ofthe oral cavity and the front and rear inner walls include a pluralityof openings. The mouthpiece includes a first manifold for containing afirst portion of the liquid and providing the first portion to thechamber through the openings of the front inner wall, a second manifoldfor containing a second portion of the liquid and providing the secondportion to the chamber through the openings of the rear inner wall, afirst port for conveying the first portion of liquid to and from thefirst manifold, a second port for conveying the second portion of liquidto and from the second manifold. The mouthpiece further includes meansfor providing an effective seal of the mouthpiece within the oralcavity. The invention is further directed to methods of collecting andanalyzing samples of fluid from the oral cavity, including the steps ofplacing the device in the oral cavity, collecting the fluid samples andconducting an analysis of the fluid samples.

The terms “reciprocating movement of liquid(s)” and “reciprocation ofliquid(s)” are used interchangeably herein. As used herein, both termsmean alternating the direction of flow of the liquid(s) back and forthover surfaces of the oral cavity of a mammal from a first flow directionto a second flow direction that is opposite the first flow direction.

By “effective fit or seal”, it is meant that the level of sealingbetween the means for directing liquid onto and about the plurality ofsurfaces in the oral cavity, e.g. an application tray, is such that theamount of leakage of liquid from the tray into the oral cavity duringuse is sufficiently low so as to reduce or minimize the amount of liquidused and to maintain comfort of the user, e.g. to avoid choking orgagging. Without intending to be limited, gagging is understood to be areflex (i.e. not an intentional movement) muscular contraction of theback of the throat caused by stimulation of the back of the soft palate,the pharyngeal wall, the tonsillar area or base of tongue, meant to be aprotective movement that prevents foreign objects from entering thepharynx and into the airway. There is variability in the gag reflexamong individuals, e.g. what areas of the mouth stimulate it. Inaddition to the physical causes of gagging, there may be a psychologicalelement to gagging, e.g. people who have a fear of choking may easilygag when something is placed in the mouth.

As used herein, “means for conveying liquid” includes structures throughwhich liquid may travel or be transported throughout the systems anddevices according to the invention and includes, without limitationpassages, conduits, tubes, ports, portals, channels, lumens, pipes andmanifolds. Such means for conveying liquids may be utilized in devicesfor providing reciprocation of liquids and means for directing liquidsonto and about surfaces of the oral cavity. Such conveying means alsoprovide liquid to the directing means and provide liquid to thereciprocation means from a reservoir for containing liquid, whether thereservoir is contained within a hand-held device containing thereciprocation means or a base unit. The conveying means also providesliquid from a base unit to a liquid reservoir contained within thehand-held device.

Inventions described herein include methods and devices useful incollecting fluid samples from the oral cavity of a mammal, e.g. a human,for analysis and diagnostic purposes. Devices of the invention not onlyprovide for collection of fluid, but also may provide a beneficialeffect to the oral cavity, e.g. cleaning or treatment.

Use of a mouthpiece according to the invention provides the ability tosample consistently over a wider area of the oral cavity for a higherquality and more uniform diagnostic fluid sample, as well as providingconsistent sample collection at specific sites in the oral cavity, as isdescribed in more detail herein below. Devices and methods of theinvention provide the advantage of preparing the fluid sample in-vivo,prior to, during, or after sampling. In certain embodiments, fluidsample stimulating agents and/or conglomeration agents that can providea more consistent, higher quality fluid sample may be introduced priorto, during, or after collection of the fluid sample. For example,coagulation agents for the collection and sampling of blood from theoral cavity may be introduced, for example, into the mouthpiece or meansfor collecting the fluid sample.

Certain methods entail collecting a fluid sample from the oral cavityfor analysis and contacting a plurality of surfaces of the oral cavitywith a liquid that is effective for providing the desired beneficialeffect to the oral cavity. In such methods, reciprocation of theliquid(s) over the plurality of surfaces of the oral cavity is providedunder conditions effective to provide the desired beneficial effect tothe oral cavity. Contact of the plurality of surfaces by the liquid maybe conducted substantially simultaneous. By substantially simultaneous,it is meant that, while not all of the plurality of surfaces of the oralcavity are necessarily contacted by the fluid at the same time, themajority of the surfaces are contacted simultaneously, or within a shortperiod of time to provide an overall effect similar to that as if allsurfaces are contacted at the same time. Collection of the fluid samplesmay be conducted prior to, or simultaneously with, or subsequent tocontacting the surfaces of the oral cavity with liquid. In certainembodiments, collection may be conducted prior to, simultaneously withand subsequent to contacting the surfaces of the oral cavity withliquid.

The conditions for providing the desired beneficial effect in the oralcavity may vary depending on the particular environment, circumstancesand effect being sought. The different variables are interdependent inthat they create a specific velocity of the liquid. The velocityrequirement may be a function of the formulation in some embodiments.For example, with change in the viscosity, additives, e.g. abrasives,shear thinning agents, etc., and general flow properties of theformulation, velocity requirements of the jets may change to produce thesame level of efficacy. Factors which may be considered in order toprovide the appropriate conditions for achieving the particularbeneficial effect sought include, without limitation, the velocityand/or flow rate and/or pressure of the liquid stream, pulsation of theliquid, the spray geometry or spray pattern of the liquid, thetemperature of the liquid and the frequency of the reciprocating cycleof the liquid.

The liquid pressures, i.e. manifold pressure just prior to exit throughthe jets, may be from about 0.5 psi to about 30 psi, or from about 3 toabout 15 psi, or about 5 psi. Flow rate of liquid may be from about 10ml/s to about 60 ml/s, or about 20 ml/s to about 40 ml/s. It should benoted that the larger and higher quantity of the jets, the greater flowrate required at a given pressure/velocity. Pulse frequency (linked topulse length and delivery (ml/pulse), may be from about 0.5 Hz to about50 Hz, or from about 5 Hz to about 25 Hz. Delivery pulse duty cycle maybe from about 10% to 100%, or from about 40% to about 60%. It is notedthat at 100% there is no pulse, but instead a continuous flow of liquid.Delivery pulse volume (total volume through all jets/nozzles) may befrom about 0.2 ml to about 120 ml, or from about 0.5 ml to about 15 ml.Velocity of jetted pulse may be from about 4 cm/s to about 400 cm/s, orfrom about 20 cm/s to about 160 in/s. Vacuum duty cycle may be fromabout 10% to 100%, or from about 50% to 100%. It is noted that vacuum isalways on at 100%. Volumetric delivery to vacuum ratio may be from about2:1 to about 1:20, or from about 1:1 to 1:10.

The liquid(s) may include at least one ingredient, or agent, effectivefor providing the beneficial effect sought, in an amount effective toprovide the beneficial effect when contacted with the surfaces of theoral cavity. For example, the liquid may include, without limitation, aningredient selected from the group consisting of a cleaning agent, anantimicrobial agent, a mineralization agent, a desensitizing agent,surfactant and a whitening agent. In certain embodiments, more than oneliquid may be used in a single session. For example, a cleaning solutionmay be applied to the oral cavity, followed by a second solutioncontaining, for example, a whitening agent or an antimicrobial agent.Solutions also may include a plurality of agents to accomplish more thanone benefit with a single application. For example, the solution mayinclude both a cleansing agent and an agent for ameliorating adetrimental condition, as further discussed below. In addition, a singlesolution may be effective to provide more than one beneficial effect tothe oral cavity. For example, the solution may include a single agentthat both cleans the oral cavity and acts as an antimicrobial, or thatboth cleans the oral cavity and whitens teeth.

Liquids useful for improving the cosmetic appearance of the oral cavitymay include a whitening agent to whiten teeth in the cavity. Suchwhitening agents may include, without limitation, hydrogen peroxide andcarbamide peroxide, or other agents capable of generating hydrogenperoxide when applied to the teeth. Other whitening agents may includeabrasives such as silica, sodium bicarbonate, alumina, apatites andbioglass.

It is noted that, while abrasives may serve to clean and/or whiten theteeth, certain of the abrasives also may serve to amelioratehypersensitivity of the teeth caused by loss of enamel and exposure ofthe tubules in the teeth.

In some embodiments, the liquid may comprise an antimicrobialcomposition containing an alcohol having 3 to 6 carbon atoms. The liquidmay be an antimicrobial mouthwash composition, particularly one havingreduced ethanol content or being substantially free of ethanol,providing a high level of efficacy in the prevention of plaque, gumdisease and bad breath. Noted alcohols having 3 to 6 carbon atoms arealiphatic alcohols. A particularly aliphatic alcohol having 3 carbons is1-propanol.

In one embodiment the liquid may comprise an antimicrobial compositioncomprising (a) an antimicrobial effective amount of thymol and one ormore other essential oils, (b) from about 0.01% to about 70.0% v/v, orabout 0.1% to about 30% v/v, or about 0.1% to about 10% v/v, or about0.2% to about 8% v/v, of an alcohol having 3 to 6 carbon atoms and (c) avehicle. The alcohol may be 1-propanol. The liquid vehicle can beaqueous or non-aqueous, and may include thickening agents or gellingagents to provide the compositions with a particular consistency. Waterand water/ethanol mixtures are the preferred vehicle.

Another embodiment of the liquid is an antimicrobial compositioncomprising (a) an antimicrobial effective amount of an antimicrobialagent, (b) from about 0.01% to about 70% v/v, or about 0.1% to about 30%v/v, or about 0.2% to about 8% v/v, of propanol and (c) a vehicle. Theantimicrobial composition of this embodiment exhibits unexpectedlysuperior delivery system kinetics compared to prior art ethanolicsystems. Exemplary antimicrobial agents which may be employed include,without limitation, essential oils, cetyl pyidium chloride (CPC),chlorhexidine, hexetidine, chitosan, triclosan, domiphen bromide,stannous fluoride, soluble pyrophosphates, metal oxides including butnot limited to zinc oxide, peppermint oil, sage oil, sanguinaria,dicalcium dihydrate, aloe vera, polyols, protease, lipase, amylase, andmetal salts including but not limited to zinc citrate, and the like. Aparticularly preferred aspect of this embodiment is directed to anantimicrobial oral composition, e.g. a mouthwash having about 30% v/v orless, or about 10% v/v or less, or about 3% v/v or less, of 1-propanol.

Yet another embodiment of the liquid is a reduced ethanol, antimicrobialmouthwash composition which comprises (a) an antimicrobial effectiveamount of thymol and one or more other essential oils; (b) from about0.01 to about 30.0% v/v, or about 0.1% to about 10% v/v, or about 0.2%to about 8% v/v, of an alcohol having 3 to 6 carbon atoms; (c) ethanolin an amount of about 25% v/v or less; (d) at least one surfactant; and(e) water. Preferably the total concentration of ethanol and alcoholhaving 3 to 6 carbon atoms is no greater than 30% v/v, or no greaterthan 25% v/v, or no greater than 22% v/v.

In still another embodiment, the liquid is an ethanol-free antimicrobialmouthwash composition which comprises (a) an antimicrobial effectiveamount of thymol and one or more other essential oils; (b) from about0.01% to about 30.0% v/v, or about 0.1% to about 10% v/v, or about 0.2%to about 8%, of an alcohol having 3 to 6 carbon atoms; (c) at least onesurfactant; and (d) water.

The alcohol having 3 to 6 carbon atoms is preferably selected from thegroup consisting of 1-propanol, 2-propanol, 1-butanol, 2-butanol,tert-butanol and corresponding diols. 1-Propanol and 2-propanol arepreferred, with 1-propanol being most preferred.

In addition to generally improving the oral hygiene of the oral cavityby cleaning, for example, removal or disruption of plaque build-up, foodparticles, biofilm, etc., the inventions are useful to diagnose andameliorate detrimental conditions within the oral cavity and to improvethe cosmetic appearance of the oral cavity. Detrimental conditions mayinclude, without limitation, caries, gingivitis, inflammation, symptomsassociated with periodontal disease, halitosis, sensitivity of the teethand fungal infection. The liquids themselves may be in various forms,provided that they have the flow characteristics suitable for use indevices and methods of the present invention. For example, the liquidsmay be selected from the group consisting of solutions, emulsions anddispersions. In certain embodiments, the liquid may comprise aparticulate, e.g. an abrasive, dispersed in a liquid phase, e.g. anaqueous phase. In such cases, the abrasive would be substantiallyhomogeneously dispersed in the aqueous phase in order to be applied tothe surfaces of the oral cavity. In other embodiments, an oil-in-wateror water-in-oil emulsion may be used. In such cases, the liquid willcomprise a discontinuous oil phase substantially homogeneously dispersedwithin a continuous aqueous phase, or a discontinuous aqueous phasesubstantially homogenously dispersed in a continuous oil phase, as thecase may be. In still other embodiments, the liquid may be a solutionwhereby the agent is dissolved in a carrier, or where the carrier itselfmay be considered as the agent for providing the desired beneficialeffect, e.g., an alcohol or alcohol/water mixture, usually having otheragents dissolved therein.

The present invention includes devices, e.g. an oral hygiene device, forexample a dental cleaning apparatus, suitable for in-home use andadapted to collect fluid samples from the oral cavity and to directliquid onto a plurality of surfaces of a tooth and/or the gingival area.In certain embodiments the surfaces of the oral cavity are contacted bythe liquid substantially simultaneously. As used herein, reference tothe gingival area includes, without limitation, reference to thesub-gingival pocket. The appropriate liquid is directed onto a pluralityof surfaces of teeth and/or gingival area substantially simultaneouslyin a reciprocating action under conditions effective to providecleaning, and/or general improvement of the cosmetic appearance of theoral cavity and/or amelioration of a detrimental condition of the teethand/or gingival area, thereby providing generally improved oral hygieneof teeth and/or gingival area. For example, one such device cleans teethand/or the gingival area and removes plaque using an appropriatecleaning liquid by reciprocating the liquid back and forth over thefront and back surfaces and inter-proximal areas of the teeth, therebycreating a cleaning cycle while minimizing the amount of cleaning liquidused.

Devices of the invention that provide reciprocation of the liquidcomprise a means for controlling reciprocation of the liquid. Thecontrolling means include means for conveying the liquid to and from ameans for directing the liquid onto the plurality of surfaces of theoral cavity. In certain embodiments, the means for providingreciprocation of the liquid comprises a plurality of portals forreceiving and discharging the liquid, a plurality of passages, orconduits, through which the liquid is conveyed, and means for changingthe direction of flow of the liquid to provide reciprocation of theliquid, as described in more detail herein below. The controlling meansmay be controlled by a logic circuit and/or a mechanically controlledcircuit.

In certain embodiments, devices for providing reciprocation may includea means for attaching or connecting the device to a reservoir forcontaining the liquid. The reservoir may be removably attached to thedevice. In this case, the reservoir and the device may comprise meansfor attaching one to the other. After completion of the process, thereservoir may be discarded and replaced with a different reservoir, ormay be refilled and used again. In other embodiments, the reciprocatingdevice will include a reservoir integral with the device. In embodimentswhere the device may be attached to a base unit, as described herein,the reservoir, whether integral with the device or removably attached tothe device, may be refilled from a supply reservoir which forms a partof the base unit. Where a base unit is utilized, the device and the baseunit will comprise means for attaching one to the other.

The device will comprise a power source for driving the means forreciprocating liquids. The power source may be contained within thedevice, e.g. in the handle of the device, for example, batteries,whether rechargeable or disposable. Where a base unit is employed, thebase may include means for providing power to the device. In otherembodiments, the base unit may include means for recharging therechargeable batteries contained within the device.

Devices for providing reciprocation of liquids will include means forattaching the device to means for directing the liquid onto theplurality of surfaces of the oral cavity, e.g. an application tray ormouthpiece. In certain embodiments, the directing means providessubstantially simultaneous contact of the plurality of surfaces of theoral cavity by the liquid. The attachment means may provide removableattachment of the mouthpiece to the device. In such embodiments,multiple users may use their own mouthpiece with the single devicecomprising the reciprocating means. In other embodiments, the attachmentmeans may provide a non-removable attachment to the mouthpiece, wherebythe mouthpiece is an integral part of the device. Devices for providingreciprocation as described above may be contained within a housing withother device components so as to provide a hand-held device suitable forproviding liquid to the directing means, as described herein below.

The means for directing the liquid onto the surfaces of the oral cavity,e.g. an application tray or mouthpiece, is comprised of multiplecomponents. The directing means comprises a chamber for maintaining theliquid proximate the plurality of surfaces, i.e.liquid-contacting-chamber (LCC). By “proximate”, it is meant that theliquid is maintained in contact with the surfaces. The LCC is defined bythe space bounded by the front inner wall and rear inner wall of themouthpiece, and a wall, or membrane, extending between and integral withthe front and rear inner walls of the mouthpiece, and in certainembodiments, a rear gum-sealing membrane. Together, the front and rearinner walls, the wall extending there between and rear gum-sealingmembrane form the liquid-contacting-chamber membrane (LCCM). The generalshape of the LCCM is that of a “U” or an “n”, depending on theorientation of the mouthpiece, which follows the alignment of the teethto provide uniform and optimized contact by the liquid. The LCCM may beflexible or rigid depending on the particular directing means. Themembrane may be located as a base membrane of the LCCM. The front andrear inner walls of the LCCM each include a plurality of openings, orslots, through which the liquid is directed to contact the plurality ofsurfaces of the oral cavity.

The LCCM design may be optimized for maximum effectiveness as it relatesto the size, shape, thickness, materials and volume created around theteeth/gingiva, nozzle design and placement as it relates to the oralcavity and the teeth in conjunction with the manifold and gingivalmargin seal to provide comfort and minimize the gagging reflex of theuser. The combination of the above provides effective contact of theteeth and gingival area by the liquid.

The LCCM provides a controlled and isolated environment with knownvolume, i.e. the LCC, to contact teeth and/or gingival area withliquids, and then to remove spent liquids, as well as debris, plaque,etc., from the LCC without exposing the whole oral cavity to liquid,debris, etc. This decreases the potential for ingestion of the liquids.The LCCM also allows increased flow rates and pressure of liquidswithout drowning the individual nozzles when significant flow rates arerequired to provide adequate cleaning, for example. The LCCM also allowsreduced liquid quantities and flow rates when required, as only the areawithin the LCC is being contacted with liquid, not the entire oralcavity. The LCCM also allows controlled delivery and duration of contactof liquid on, through and around teeth and the gingival area, allowingincreased concentrations of liquids on the area being contacted by theliquid, thereby providing more effective control and delivery of liquid.

The LCCM may also allow controlled sampling of the oral cavity due toprecise positioning of the mouthpiece in the oral care cavity for use indetection or diagnostics. It can also provide capability to image and/ordiagnose gum health through a variety of methods. The system alsoprovides the ability to expand functionality for cleaning and/ortreating other oral cavity areas such as, but not limited to, thetongue, cheeks, gingival, etc.

In some embodiments, samples are collected from the oral cavity fordiagnostic analysis. Advantages of controlled sampling of the oralcavity may include real-time analysis and feedback to the user,consistent sampling due to the mouthpiece, and the ability to create abaseline of oral cavity conditions for the user and automaticallyanalyze trends over time for personalized analysis. The mouthpieceprovides an excellent opportunity for consistent collection of samplesof various fluids in the oral cavity. By “consistent collection”, it ismeant that the collection of fluids, and thus the fluid samples, areunaffected by compliance or the technique employed by the user. Themouthpiece may be secured in the user's mouth in the same fashion everytime, thus placing the means for collecting the fluid sample in the samelocation for every sample collection. In addition, the collectionenvironment may be consistent and controlled every time. In certainembodiments, the sampling environment and/or location may be confirmedvia feedback from sensor(s) placed in the mouthpiece.

The user may benefit from routine and regular tests to understand theirpersonal baseline, as many diagnostic tests vary from one individual toanother. The user's baseline may be determined over time, allowing athorough and proper analysis through each use of the system.

Several types of fluid may be collected from the oral cavity foranalysis. They may include, but are not limited to, gas, gingivalcrevicular fluid (GCF), blood, saliva, and any combination thereof.

For example, a variety of beneficial diagnostic analyses may beperformed using the gas in the oral cavity. This invention allows forconsistent collection of oral cavity gases for repeatable analysis. Abaseline may be determined and tracked over time, integrating trendanalysis and providing feedback to the user.

When positioned in the mouth, the mouthpiece may create a vacuum in theoral cavity with one or more nozzles, drawing air from the oral cavityinto the device for storage and/or analysis. The collection may be donein a variety of ways, such as running the system in vacuum mode afterthe appliance is inserted into the mouth, but before the liquid deliverycycle begins. In this case, the same nozzles used for delivery andvacuum of the cleaning and treatment liquids may be used to collect theoral cavity gas, with no extra manifolds, isolated chambers, or similarstructures.

The mouthpiece may also have a dedicated manifold for collecting oralcavity air that is separate from the cleaning and treatment liquiddelivery system of the mouthpiece. The manifold may be connected to oneor more nozzles in the appliance, similar to that of the deliverysystem. It may also be connected to any other nozzles or ports in themouthpiece, appropriately placed for oral cavity gas collection. In someembodiments, the mouthpiece may have an orifice which collects gas justabove the tongue in the center of the oral cavity.

The oral cavity gas sample may be collected before cleaning/treatment,during cleaning and treatment (depending on the collection portlocation), after cleaning/treatment, or any combination thereof. Avariety of diagnostics may be performed using the oral cavity gas,benefiting from consistent collection techniques to yield the best andmost consistent results possible.

Oral malodor, or halitosis, is a common condition in which the source ofthe odor typically originates in the oral cavity, usually at the dorsumof the tongue. Certain oral bacteria produce malodorous volatile sulfurcompounds (VSCs), including hydrogen sulfide, methyl mercaptan anddimethyl sulfide. A number of methods to detect levels of VSCs in theair in the oral cavity exist in the art. Collectively these methods aresufficiently sensitive to detect these odorous compounds, butconsistency of results is highly user-dependent. All of these collectionmethods could benefit from consistent collection or sampling techniqueto ensure consistent, robust measurements. Such controlled sampling maybe achieved through sample collection via the appliance.

The device may collect a sample of gas from the oral cavity, and measurethe levels of VSCs present (ppb) via a zinc oxide semiconductor sensoras known in the art. The measurement may be recorded whenever the deviceis used by the user, such as twice daily, daily or weekly and trackedover time. As an example, data from an initial 30-day period may be usedto establish a baseline against which all subsequent measurements may becompared. Any deviations from normal trends may trigger a feedback alertto the user for monitoring development of and/or treatment progress ofhalitosis. Alternatively, the device may collect a gas sample over thetongue and detect VSCs via gas chromatography in the base station. Anadditional alternative may include sample collection in the device,storage of the sample in an appropriate detachable compartment, andshipment of the sample to an outside laboratory for analysis. In eachcase, the user may receive the added benefit of consistent,compliance-free monitoring of VSC levels in the oral cavity, which theywould not receive through available oral hygiene measures. In addition,users may benefit from tracking this information over time, which mayallow for immediate alerts for any adverse changes in VSC levels and mayenable the individual to take immediate corrective actions.

Alternatively, a variety of beneficial diagnostic analyses may beperformed using the Gingival Crevicular Fluid (GCF) in the oral cavity.GCF is a fluid found in the gingival pocket of the oral cavity, and isvery useful in various types of diagnostics. Several methods ofcollecting the GCF exist in the art. These include inserting a probe inthe gingival pocket to extract the fluid, and swabbing the fluid fromthe pocket. While these methods effectively retrieve the fluid, sampleto sample inconsistencies are possible. The mouthpiece discussed hereallows for consistent GCF collection.

Each time the mouthpiece is inserted into the mouth, it is located inthe same position. For GCF sampling, a plurality of nozzles, ormicropipettes, are placed at regularly or randomly spaced intervalsabout the mouthpiece near and/or directed at the gum line between theteeth and gums and/or within the gingival pocket. The nozzles ormicropipettes may be located along the outer, inner, or both walls ofthe chamber of the mouthpiece. A suitable buffer solution is directedinto the gum pocket from one or more nozzles, extracting and mixing withthe GCF. A vacuum is then created at the nozzles to collect the mixedsolution and move it into the device for analysis. This may be donebefore, during, or after the cleaning/treatment process, or anycombination thereof. Alternatively, the micropipettes and or nozzles canbe utilized to collect the sample without introduction of a bufferingsolution, or pretreatment means, utilizing vacuum and/or capillaryaction to promote sample collection.

Gingivitis, or inflammation of the gum tissue, is a common,non-destructive form of gum disease. It is most commonly caused bybiofilm (plaque) accumulation on the teeth. If left untreated,gingivitis may progress to irreversible periodontal disease and lead toloss of tissue, bone and tooth attachment. Gingivitis is reversible andmay be easily treated with an oral hygiene routine to remove plaquebiofilm on a daily basis. Despite this, most adults will haveoccurrences of gingivitis at multiple sites in the mouth over theirlifetime and could benefit from routine monitoring of gum health. GCF isan inflammatory exudate that contains a number of biomarkers includingbacterial antigens, inflammatory markers, and bacterial and hostmetabolites. Many of these markers are specific to gingivitis andperiodontitis and could be used as target analytes to monitor gingivialhealth. However, since conventional GCF collection is difficult, timeconsuming and requires a trained professional, it is usually reserved asa research methodology and is not routinely utilized in dental offices.Most adults would therefore never receive the benefit of such ananalysis.

In some embodiments, the device may use microfluidic immunoassays toanalyze GCF samples to detect antigens specific to bacteria associatedwith gingivitis, or periodontitis, inflammatory markers and/ormetabolites associated with gingivitis and/or periodontitis. Theanalysis may be performed in the device itself, or in the base stationon a daily, weekly or monthly basis. The results may be tracked overtime to monitor signs of development and/or progression of gum disease,and status of treatment. An initial specified period may be used toestablish a baseline against which all subsequent measurements could becompared. A warning appropriate to the level of disease detected may beissued to the user through the device and results may also be forwardedto a dental professional for further evaluation.

In another embodiment, a variety of beneficial diagnostic analyses maybe performed using saliva from the oral cavity. Though many collectionmethods for saliva exist in the art, these often require professionaltraining with proper technique to collect the correct quantity of thedesired fluid. The sample must then be analyzed in a secondary process.The mouthpiece discussed here allows for consistent collection of salivafor repeatable analysis.

Each time the mouthpiece is inserted into the mouth, it is located inthe same position. For saliva sampling, a plurality of nozzles arelocated throughout the oral cavity. As the system operates,cleaning/treating liquid may move through the appliance, into the oralcavity, and out of the oral cavity. As the fluid is moving through theoral cavity, it may mix with saliva and therefore move saliva throughthe system. The mixed solution may be analyzed in the device as it isfunctioning or stored for later analysis. If desired, several means maybe used to increase saliva production and increase the percentage ofsaliva in the overall system fluid mixture. Methods include, but are notlimited to, use of a salivation-inducing fluid during system operation,user exposure to specific saliva-inducing smells, electricalstimulation, ultrasonic stimulation, or mechanical stimulation.

Alternatively, a saliva mixture may be collected through a separateand/or specific manifold in the mouthpiece. Through any means ofcollection, the saliva may be collected before, during, or after thecleaning/treatment process, or any combination thereof.

The mouthpiece may also have a collection means that contacts the tongueto suck or absorb saliva from it. The probe or pad contacting the tonguemay have one or more nozzles that pull a vacuum on the tongue to collectthe saliva. Alternatively, the pad may absorb saliva and automaticallyextract the saliva in a secondary process, or otherwise analyze thesaliva directly on the pad. As in the above techniques, this method istechnique- and compliance-free for the user.

Saliva samples may be utilized as diagnostic samples for a number oforal health conditions and analyzed via a variety of diagnostic methods.

The device may diagnose caries risk through microfluidic immunoassaysperformed on saliva samples to detect proteinaceous antigens specific toS. mutans and/or Lactobacillus bacteria with fluorescence detection ofoutput. The assay may be performed weekly or monthly, and a warningregistered to the user if the levels of bacteria were to surpass thethreshold for high caries risk. Alternatively, the device may measurethe buffering capacity of the saliva using a series of absorbent padsembedded with pH indicators, as known in the art. An alert to the usermay be triggered by low buffering capacity results, indicating a highrisk for caries. As an additional alternative, the device may directlymeasure the concentration of fluoride ions in the saliva using afluoride ion specific electrode. A baseline may be established bymonitoring the fluoride ion concentration on a daily or weekly basis fora specified period of time. Any significant deviations from baselineconcentration trends would trigger an alert to the user.

The device may use microfluidic immunoassays to analyze saliva samplesfor the presence of antigens specific to bacteria associated withgingivitis and periodontitis. The assay may be performed daily, weeklyor monthly, with the data being recorded over time. Any adversedeviations from normal trends would alert the user to consult a dentalprofessional for further evaluation.

Alternatively, the device may analyze saliva samples using a lateralflow technology (LFT) test. After collection, the sample may be mixedwith a bacterial cell lysing agent and the resulting mixture applied toa lateral flow devise in the base station which may detect antigensspecific to S. mutans for assessing carries risk as known in the art.The lateral flow device may also detect antigens specific to bacteriaassociated with gingivitis and/or periodontisis either alone or incombination with S. mutans antigens. It may also react with thiols involatile sulfur compounds (VSCs), or detect antigens specific toVSC-producing bacteria to produce a detectable color change with theintensity of the color correlating with the concentration of VSCspresent. The lateral flow test may be performed in the base station withrefillable LFT strips either specific for a single condition, or stripsthat will detect a combination of antigens and/or chemistries formultiple oral conditions. Results may be assessed in the base station.Alternatively, the test may be performed externally, with the userapplying the sample collected and prepared by the device to the LFTstrip with test results read visually by the user as the appearance of acolored indicator or color change on the strip. Conversely, analysis ofthe strip can occur automatically through digital image analysis.

Alternatively, the device may analyze saliva samples to determine theprevalence of disease-associated bacteria within the entire populationin the sample using quantitative Polymerase Chain Reaction (qPCR)analysis. The analysis may be performed within the device or basestation using microfluidic techniques or, alternatively, the sample maybe collected and contained within the device and sent to an outsidelaboratory for analysis. The analysis may be performed daily, weekly ormonthly and a high number of S. mutans or Lactobacilli would trigger awarning to the user that they may be at risk for developing caries,whereas high counts of organisms associated with periodontitis wouldalert the user to a possible prevalence for gum disease. In each casethe analysis could be performed daily, weekly or monthly and trackedover time to identify significant deviations from normal trends.

Alternatively, the device may analyze saliva samples using DNA-DNAhybridization techniques to determine the bacterial population profileof the sample. This information may be recorded daily, weekly or monthlyand tracked over time to monitor changes in relative amounts ofdifferent bacteria in the entire population. Significant adversepopulation shifts would trigger a warning to the user for increased riskof disease onset or progression (such as high risk for caries orperiodontal disease). The information may also be used to track theprogress of disease treatment.

In each of these cases, the user would be highly unlikely or unable toperform the diagnostic test described, and most are not routinelypracticed in dental offices. The mouthpiece may provide the addedbenefit of acquiring this information in a consistent manner on aregular basis, and may enable the user to closely monitor their oralhealth status and take any required corrective measures in a timelyfashion.

The collection methods and diagnostic analysis discussed above may usedin conjunction with one another, in any combination. Due to theflexibility of the system, collection of each sample only needs to occurwhen determined or pre-established, rather than during every use. Forexample, some samples may need to be taken only once a week, whileothers ideally may be taken one or more times a day. The system mayautomatically adjust the sampling plan as needed for each individual,based on results and predetermined criteria.

In addition, much information and analysis can be derived from colormetrics obtained from various parts of the oral cavity. The color,texture, and opacity of the gums, cheeks, and/or tongue is an excellentindicator of health conditions when analyzed as a single data point oras a trend over time. The color, texture, and opacity of teeth may alsobe analyzed and tracked to understand benefits of whitening efforts orto monitor degradation from lifestyle behavior or health deficiencies.Methods known in the art for analyzing color, textures and opacityinclude light sources with detectors to look for specificwavelengths/colors, CCD (charge coupled device) and CMOS (complementarymetal oxide semiconductor) image sensors to compare a live image againstreference data/images, and others. The appropriate sensors, detectors,and light sources may be embedded in the appliance so that color,texture, and/or opacity analysis may be performed before, during, orafter the cleaning/treatment cycle. The mouthpiece of this invention, aswell as the incorporated sensors, will be placed in the same positionevery time with consistent environmental conditions, creating repeatableand robust data. There may be no special interaction for this functionby the user, and they may be provided with feedback over time as thedevice is regularly used. This data would not normally be collected bythe user without extra effort involving separate devices requiringcorrect technique and interpretation.

The device may analyze tooth shade using methods photoimaging techniquesknown in the art that employ a CCD camera, spectrophotometer and imagingsoftware to map a tooth and record the L, a, b color scale value for thearea. This data could be collected on a daily or weekly basis and alertthe user to development of staining, plaque and/or tartar development.

The device may utilize quantitative light fluorescence (QLF) to diagnoseearly carious lesions. The device may employ two-way optics toilluminate the tooth surface with 488 or 655 nm light and detect theresulting fluorescence. Healthy tooth surfaces would fluorescence green,while areas of demineralization would appear gray. These demineralizedlesions are reversible with topical fluoride treatment but are generallyundetectable using traditional methods such as dental probes. Theappliance may acquire this data on a daily, weekly or monthly basis andalert the user to the need for such treatment before the formation ofirreversible damage to the tooth surface.

In addition to the oral health diagnostics as described above, thedevice can also be utilized and expanded to diagnose general healthconditions and biomarkers related to systemic health, including but notlimited to cancers, hypertension, diabetes, etc.

Combinations of different biomarkers and samples can be combined toprovide a more robust analysis and diagnosis for specific conditions andprovide improved results, such as using GCG and saliva samples, and/orchecking multiple biomarkers that are linked to a specific condition.The presence of one biomarker might also automatically trigger samplingand analysis of other biomarkers to improve diagnostic results.

Diagnostic results can also be used to provide automated treatment forthe condition, and/or direct the user to purchase a specific product toaddress a potential condition. The treatment could also be customized byadding appropriate additives to the cleaning formulation for a specificuser depending on their diagnostic result. As an example, adding aantibacterial, halitosis reducing agent, sensitivity agent, whiteningagent, fluoride, and/or any combination of these or other additives totreat an oral and/or systemic condition.

The thickness of the walls of the LCCM may be within a range of 0.2 mmto 1.5 mm, to provide necessary physical performance properties, whileminimizing material content, and optimizing performance. The distancebetween the inner walls of the LCCM to the teeth may be from about 0.1mm to about 5 mm, and more typically an average distance of about 2.5 mmto provide maximum comfort, while minimizing customization and LCCvolume requirements.

The size and shape of the mouthpiece preferably utilizes three basicuniversal sizes (small, medium and large) for both the top and bottomteeth, but the design provides mechanisms to allow different levels ofcustomization as required to ensure comfort and functionality to theindividual user. The device may incorporate a switching mechanism, whichwould allow it to be operable only when in the correct position in themouth. The mouthpiece may include both upper and lower sections toprovide substantially simultaneous contact of the plurality of surfacesof the oral cavity by liquid. In an alternate embodiment the upper andlower sections may be cleaned utilizing a single bridge that could beused on the upper or lower teeth and gums of the user (first placed onone portion for cleaning, then subsequently placed over the otherportion for cleaning).

The number and location of openings, also referred to herein as slots,jets or nozzles, contained within the inner walls of the mouthpiecethrough which the liquid is directed will vary and be determined basedupon the circumstances and environment of use, the particular user andthe beneficial effect being sought. The cross-sectional geometry of theopenings may be circular, elliptical, trapezoidal, or any other geometrythat provides effective contact of the surfaces of the oral cavity bythe liquid. The location and number of openings may be designed todirect jets of liquid in a variety of spray patterns effective forproviding the desired beneficial effect. Opening diameters may be fromabout 0.1 to about 3 mm, or from about 0.2 mm to about 0.8 mm, or about0.5 mm, to provide effective cleaning and average jet velocities andcoverage.

Optimal opening placement and direction/angles allows coverage ofsubstantially all teeth surfaces in the area if the oral cavity to becontacted by liquid, including but not limited to interdental, top,side, back, and gingival pocket surfaces. In alternate embodiments, theopenings could be of different sizes and different shapes to providedifferent cleaning, coverage and spray patterns, to adjust velocities,density and fan patterns (full cone, fan, partial, cone, jet), or due toformulation consideration. Nozzles could also be designed to be tubularand or extend from the LCCM to provide directed spray, or act assprinkler like mechanism to provide extended coverage across the teeth,similar to a hose sprinkler system. The nozzles are preferably integralto the inner walls of the LCCM and can be incorporated into the innerwalls through any number of assembly or forming techniques known in theart (insert molded, formed in membrane through machining, injectionmolding, etc.).

The LCCM may be an elastomeric material such as ethylene vinyl acetate(EVA), thermoplastic elastomer (TPE), or silicone, to allow motion ofthe inner walls and provide a greater jet coverage area with minimalmechanics, reducing the volumetric flow requirements to achieveoptimized performance, while providing a softer and more flexiblematerial to protect the teeth if direct contact with the teeth is made.A flexible membrane may also provide acceptable fitment over a largerange of users, due to its ability to conform to the teeth.Alternatively, the LCCM could be made of a rigid or semi-rigid material,such as but not limited to a thermoplastic.

It may be desirable, although not required, to have motion of the LCCMrelative to the teeth. Movement of the LCCM, and subsequently the nozzledirection during the cleaning and/or treatment operation, providesincreased coverage of the teeth/gums, while minimizing the number ofnozzles/fluidic jets required to provide this coverage for cleaningand/or treatment. It also reduces the required overall fluid flowrequirement, which reduces the total liquid fluid requirement andoverall device overhead as it relates to provide the appropriate flow,resulting in a smaller, lighter, and useable device. This motion alsoallows the device to provide a more universal fit for the user (samesized LCCM can be used for different users), while also allowingcompensation for minor misplacement/orientation of the LCCM over theusers teeth/gums.

In some embodiments, motion of the LCCM is provided throughpressurization, pulsation, and movement of liquid through the manifolds.In alternate embodiments, this motion can be achieved through vibration,sonic, or ultrasonic mechanism. This motion can also be provided througha separate network of tubes and/manifolds constructed within or attachedto the LCC, which can be charged or discharged with liquid and/or air tocreate a desired motion of the membrane. In addition, motion of the LCCMmay be the result of the motion of the user's jaw or teeth. In analternate embodiment, the LCCM motion system can also includemechanically moving the LCCM via a track-like guided reciprocatingmotion, the track being created by the teeth. In another alternateembodiment, the desired LCCM motion can be created by using one or amultiple of linear motor systems, which allow sequential motion viamultiple permanent magnet/coil pairs located in strategic locations onthe mouthpiece to provide optimized cleaning and treatment sequences fordirecting jets and cleaning elements. In yet another alternativeembodiment, motion may be created by shape memory materials orpiezoelectrics.

In the preferred embodiment, the system provides pulsation through avariety of elements, including through the delivery manifold, channels,and nozzles, the vacuum manifolds, channels and nozzles, and through thereciprocation/reversal of flow, where the delivery channels become thevacuum channels, and the vacuum channels the delivery channels.Pulsation of the fluid results in a varying pressure of the fluid withinthe elements described creating the desired motion of the LCCM asdescribed. The LCCM is designed to work with the fluid pulsation meansprovided to create the necessary motion and movement/direction of thenozzles in the X, Y and Z directions, through the combination ofmaterials and design of the LCCM, while still providing the necessaryperformance required to minimize leakage into the oral cavity andwithout compromising structural integrity of the mouthpiece, includingthe LCCM.

The movement/pulsation of the elements can be coordinated or random. Thepulsation can be provided at a fixed frequency, multiple frequencies,and/or out of phase for the individual elements to create the desiredmotion. It is not necessary to pulsate all of the elements at once. Asan example, in some cases only the delivery elements may be required tobe pulsated, while the vacuum is not pulsated.

In addition, the LCCM could include cleaning elements and/or spacersthat would move relative to the LCCM to provide some effect to the teethand/or gums. These cleaning elements and/or spacers can also be used toconstrain the motion of the LCCM if required to maintain a minimumdistance between the LCCM and teeth/and/or gums during motion andfitment of the device to the user. This provides a minimum distancebetween the nozzle located within the LCCM and the surface to be treatedand cleaned, preventing a nozzle from being blocked, and preventingfluid delivery and/or removal. As the spacer is moving with the movementof the LCCM during cleaning and/or treatment, it does not prevent orinhibit cleaning and/or treatment of surfaces that are in direct contactwith the spacer, as this engagement location on the surface isconstantly changing. In addition, the motion of the spacer relative tothe surface being cleaned/treated may have additional beneficial effectthrough cleaning and/or stimulation of the contact surface during thecleaning/treatment process, similar to a tooth brushing or gum massaginglike action.

In an alternate embodiment, the LCCM could also include abrasiveelements such as filaments, textures, polishing elements, additives(silica, etc.), and other geometric elements that could be used forother cleaning and/or treatment requirements as well as ensuring minimaldistance between the teeth and LCCM for, but not limited to, treatment,cleaning, and positioning.

In some embodiments, the LCCM may contain a sensing means device and/orswitch, which determines if the mouthpiece is in the correct positionover the teeth in the oral cavity and which will not allow the device toactivate unless this position is verified through the switch/sensor.Also, if the mouthpiece is moved or dislodged from this position duringuse, it will immediately stop functioning. An override switch can beincorporated during application tray cleaning.

The sensing means can be manual, as in a manual switch(s) such as amembrane switch, or other switches known in the art. Other contact andnon-contact sensing means can also be used, such as ultrasonic, Hall(magnetic), frequency, pressure, capacitance, inductance, laser, opticaland other sensing means and devices know in the art.

The sensing means would be located in the appliance in such a way thatit would measure change or provide a signal when the user positioned themouthpiece in an acceptable position within the oral cavity, andenabling the device to operate the appropriate cycle.

An alternate and potentially redundant means of determining if theposition and orientation of the mouthpiece is correct is to monitor thecurrent and/or power required by the drive motor(s). If the current isabove the acceptable range, it is an indication that the mouthpiece maybe positioned incorrectly, either blocking delivery of the fluid or theremoval/vacuum of fluid from the LCCM. If the current it too low, it isan indication that there is no restriction to vacuum or delivery flow,and again can be indicative of the mouthpiece not being in the correctposition within the user's mouth, such as if the user accidently removedthe device before the cleaning/treatment cycle was complete, or startedthe cycle when not positioned correctly within the oral cavity.

The LCCM could be created via a variety of methods such as, but notlimited to, machining, injection molding, blow molding, extrusion,compression molding, and/or vacuum forming. It can also be created inconjunction with the manifold, but incorporating the manifold circuitrywithin the LCC, and/or over-molded onto the manifold to provide aunitary construction with minimal assembly.

In one embodiment, the LCCM may be fabricated separately and thenassembled to the manifolds, utilizing any number of assembling andsealing techniques, including adhesives, epoxies, silicones, heatsealing, ultrasonic welding, and hot glue. The LCCM is designed in a waythat, when assembled with the manifold, it effectively and efficientlycreates the preferred dual manifold design without any additionalcomponents.

In certain embodiments, the LCCM can also be designed or used to createthe gingival sealing area. In certain embodiments, a vacuum is appliedwithin the LCC, which improves the engagement of the mouthpiece to forma positive seal with the gingival in the oral cavity. In otherembodiments, a pressure is applied outside the LCCM, within the oralcavity, which improves the engagement of the mouthpiece to form apositive seal with the gingival in the oral cavity. In yet otherembodiments, a denture-like adhesive may be applied around themouthpiece during the initial use to provide a custom reusable resilientseal when inserted into the oral cavity for a particular user. It wouldthen become resiliently rigid to both conform and provide a positiveseal with the guns and on subsequent applications. In anotherembodiment, the seal could be applied and/or replaced or disposed ofafter each use.

The directing means also comprises a first manifold for containing theliquid and for providing the liquid to the LCC through the openings ofthe front inner wall, and a second manifold for containing the liquidand for providing the liquid to the chamber through the openings of therear inner wall. This design provides a number of different options,depending on what operation is being conducted. For instance, in acleaning operation, it may be preferable to deliver jets of liquid intothe LCC directly onto the teeth from one side of the LCC from the firstmanifold and then evacuate/pull the liquid around the teeth from theother side of the LCC into the second manifold to provide controlledinterdental, gumline and surface cleaning. This flow from the one sideof the LCC could be repeated a number of times in a pulsing actionbefore reversing the flow to deliver jets of liquid from the secondmanifold and evacuating/pulling the liquid through the back side of theteeth into the first manifold for a period of time and/or number ofcycles. Such liquid action creates a turbulent, repeatable andreversible flow, thus providing reciprocation of the liquid about thesurfaces of the oral cavity.

In a treatment, pre-treatment, or post-treatment operation it may bepreferable to deliver the liquid through one or both manifoldssimultaneously, flooding the chamber and submerging the teeth for aperiod of time and then evacuating the chamber after a set period oftime through one or both manifolds.

In alternate embodiments, the manifold can be of single manifold designproviding pushing and pulling of the liquid through the same sets ofjets simultaneously, or can be any number of manifold divisions toprovide even greater control of the liquid delivery and removal of thecleaning and liquid treatment. In the multi-manifold also can bedesigned to have dedicated delivery and removal manifolds. The manifoldscan also be designed to be integral to and/or within the LCCM.

The material for the manifold would be a semi-rigid thermoplastic, whichwould provide the rigidity necessary not to collapse or burst during thecontrolled flow of the liquids, but to provide some flexibility whenfitting within the user's mouth for mouthpiece insertion,sealing/position and removal. To minimize fabrication complexity, numberof components and tooling cost, the dual manifold is created whenassembled with the LCCM. The manifold could also be multi-component toprovide a softer external “feel” to the teeth/gums utilizing a lowerdurometer elastomeric material, such as, but not limited to, acompatible thermoplastic elastomer (TPE). The manifold could be createdvia a variety of methods such as, but not limited to machining,injection molding, blow molding, compression molding, or vacuum forming.

The directing means also comprises a first port for conveying the liquidto and from the first manifold and a second port for conveying theliquid to and from the second manifold, and means for providing aneffective seal of the directing means within the oral cavity, i.e. agingival seal. In certain embodiments, the first and second ports mayserve both to convey liquid to and from the first and second manifoldsand to attach the mouthpiece to the means for providing liquid to themouthpiece. In other embodiments, the directing means may furtherinclude means for attaching the directing means to means for providingliquid to the directing means.

FIG. 1 is a schematic drawing of an embodiment of a method and systemaccording to the present invention. The figure shows system 200, withcomponents including: means for providing reciprocation of liquid in theoral cavity 202, means for directing the liquid onto the plurality ofsurfaces of the oral cavity, in this instance shown as application tray100, and liquid supply reservoir 290. Means for providing reciprocationof liquids may include, in this embodiment, delivery/collection device210, optional reciprocating flow controller 230, tubes 212, 216, and 292for conveying the liquid throughout the system, and liquid one-way flowvalves 214, 218 and 294. Tubes 232 and 234 provide for conveyance of theliquid from reciprocating flow controller 230 to application tray 100.

In some embodiments, delivery/collection device 210 may be a pistonpump. Liquid supply reservoir 290 may be made of glass, plastic ormetal. Liquid supply reservoir 290 may be integral to system 200 andrefillable. In some embodiments, liquid supply reservoir 290 may be areplaceable liquid supply, such as a single or multi-use cartridge,detachably connected to system 200.

In some embodiments, liquid supply reservoir 290 and/or tubes 212, 292,may include a heat source to pre-warm the liquid prior to direction intoapplication tray 100 for application to the surfaces of the oral cavity.The temperature should be maintained within a range effective to provideefficacy and comfort to the user during use.

Application tray 100, discussed in detail herein below, could beintegral with, or detachably connected to reciprocating means 202 by wayof tubes 232, 234 and further attachment means (not shown). It could beone or two sided with internally, easily cleanable filters for trappingfood particles. When positioned within the oral cavity, e.g. about theteeth and gums, tray 100 forms an effective fit or seal against thegums, and includes means to direct liquid against surfaces of the oralcavity, e.g. surfaces of the teeth.

Liquid in liquid supply reservoir 290 flows through tube 292 todelivery/collection device 210. Liquid flow through tube 292 iscontrolled by one-way flow valve 294. From delivery/collection device210, liquid flows through tube 212 to reciprocating flow controller 230.One-way flow valve 214 controls the liquid flow through tube 212. Liquidflows from reciprocating flow controller 230 to application tray 100either through tube 232 or 234, depending on the flow direction settingof flow controller 230. Liquid flows from application tray 100, througheither tube 234 or 232 back to reciprocating flow controller 230, andfrom reciprocating flow controller 230 to delivery/collection device210, through tube 216. One-way flow valve 218 controls the liquid flowthrough tube 216.

The actions of delivery/collection device 210 may be controlled by alogic circuit, which may include a program to start the reciprocationcycle, a program to execute the reciprocation cycle, i.e. to causeliquid to be reciprocated about the teeth, thereby providing thebeneficial effect to the oral cavity, e.g. cleaning the teeth, a programto empty application tray 100 at the end of the reciprocation cycle, anda self-cleaning cycle to clean the system between uses, or at pre-set orautomatic cleaning times.

Though not shown, a face panel with a series of switches and indicatorlights may also be incorporated into system 200. Switches may include,but are not limited to, on/off, fill application tray 100, run thereciprocation program, empty system 200, and clean system 200.Indicator, or display, lights include, but are not limited to, power on,charging, reciprocation program running, system emptying, cleaningresults or feedback, and self-cleaning cycle in operation. Inembodiments where liquid is pre-warmed prior to direction intoapplication tray 100, a display light could be used to indicate that theliquid is at the proper temperature for use.

One method of using system 200 to clean teeth is as follows. In thefirst step, the user positions application tray 100 in the oral cavityabout the teeth and gingival area. The user closes down on tray 100,thereby achieving an effective fit or seal between gums, teeth and tray100. In use of the system according to the invention, the user pushes astart button initiating the cleaning process. The cleaning process is asfollows:

-   -   1. Delivery/collection device 210 is activated to begin drawing        cleaning liquid from liquid supply reservoir 290 through tube        292 and one-way valve 294.    -   2. Once delivery/collection device 210 is sufficiently filled,        delivery/collection device 210 is activated to begin dispensing        cleaning liquid to application tray 100 via tube 212, one-way        valve 214, reciprocating flow controller 230, and tube 232.        Cleaning liquid will be prevented from flowing through tubes 216        and 292 by one-way flow valves 218 and 294, respectively.    -   3. Delivery/collection device 210 is activated to begin drawing        cleaning liquid from application tray 100 through tube 234, then        through reciprocation flow controller 230, then through tube 216        and one-way valve 218. Cleaning liquid will be prevented from        flowing through tube 212 by one-way flow valve 214. If there is        insufficient cleaning liquid to adequately fill        delivery/collection device 210, additional cleaning liquid may        be drawn from liquid supply reservoir 290 through tube 292 and        one-way valve 294.    -   4. The direction of the liquid flow is then reversed.    -   5. To reciprocate the cleaning liquid, steps 2 and 3 are        repeated after the flow direction is reversed, cycling cleaning        liquid between delivery/collection device 210 and application        tray 100, using tubes 234 and 232, respectively.    -   6. The reciprocation cycle described continues until the time        required for cleaning has expired, or the desired numbers of        cycles are complete.

It is noted that there may be a delay between steps 2 and 3 (in eitheror both, directions), allowing a dwell time where the liquid is allowedto contact the teeth without flow.

FIG. 2 is a schematic drawing of a first alternative embodiment of asystem and method according to the present invention. The figure showssystem 300, with components including: means for providing reciprocationof liquid in the oral cavity 302, liquid reservoir 370, liquid supplyreservoir 390, and means for directing liquid onto and about theplurality of surfaces in the oral cavity, in this instance shown asapplication tray 100. Means for providing reciprocation of fluids mayinclude delivery device 310, collection device 320, optionalreciprocating flow controller 330, tubes 312, 322, 372, 376, and 392,and solution one-way flow valves 314, 324, 374, 378, and 394. Tubes 332and 334 provide for conveyance of the liquid from reciprocating flowcontroller 330 to application tray 100.

In some embodiments, delivery device 310 and collection device 320 maybe individual, single action piston pump. In other embodiments, deliverydevice 310 and collection device 320 may be housed together as a duelaction piston pump. Liquid supply reservoir 390 and liquid reservoir 370may be made of glass, plastic or metal. Liquid supply reservoir 390 maybe integral to system 300 and refillable. In some embodiments, liquidsupply reservoir 390 may be a replaceable liquid supply, detachablyconnected to system 300.

In some embodiments, any of liquid supply reservoir 390, liquidreservoir 370, or tubes 312, 372, 392, may include a heat source topre-warm liquid prior to direction into application tray 100 forapplication to the plurality of surfaces in the oral cavity. Thetemperature should be maintained within a range effective to providecomfort to the user during use.

Application tray 100, could be integral with, or detachably connected tocleaning reciprocating means 302 by way of tubes 332, 334, and otherattachment means (not shown).

Liquid in liquid supply reservoir 390 flows through tube 392 to liquidreservoir 370. Liquid in reservoir 370 flows through tube 372 todelivery device 310. Liquid flow through tube 372 may be controlled byone-way flow valve 374. From delivery device 310, liquid flows throughtube 312 to reciprocating flow controller 330. One-way flow valve 314controls the liquid flow through tube 312. Liquid flows fromreciprocating flow controller 330 to application tray 100 through tube332 or 334, depending on the flow direction setting of flow controller330. Liquid flows from application tray 100, through tube 334 or 332back to reciprocating flow controller 330, and from reciprocating flowcontroller 330 to collection device 320, through tube 322. One-way flowvalve 324 controls the liquid flow through tube 322. Finally, cleaningliquid flows from collection device 320 to liquid reservoir 370 throughtube 376. One-way flow valve 378 controls the liquid flow through tube376.

The actions of delivery device 310 and collection device 320 arecontrolled by a logic circuit, which may include a program to the startof the reciprocation cycle, a program to execute the reciprocationcycle, i.e. to cause solution to be reciprocated about the plurality ofsurfaces of the oral cavity, thereby providing the beneficial effect, aprogram to empty application tray 100 at the end of the reciprocationcycle, and a self-cleaning cycle to clean the system between uses, or atpre-set or automatic cleaning times.

System 300 may also include switches such as on/off, fill applicationtray 100, run the cleaning program, empty system 300, and clean system300, and indicator, or display, lights including, but are not limitedto, power on, charging, cycle program running, device emptying, resultsor feedback, and self-cleaning cycle in operation. In embodiments whereliquid is pre-warmed prior to direction into application tray 100, adisplay light could be used to indicate that the liquid is at the propertemperature for use.

One method of using system 300 to clean teeth is as follows. Prior touse, cleaning liquid in liquid supply chamber 390 flows through tube 392and one-way valve 394 to cleaning liquid reservoir 370. In someembodiments, liquid supply reservoir 390 is now disconnected from system300.

In the first step, the user positions application tray 100 in the oralcavity about the teeth and gingival area. The user closes down on tray100, thereby achieving an effective fit or seal between gums, teeth andtray 100. The user pushes a start button initiating the cleaningprocess. The cleaning process is as follows:

-   -   1. Delivery device 310 is activated to begin drawing cleaning        liquid from cleaning liquid reservoir 370 through tube 372 and        one-way flow valve 374.    -   2. Once delivery device 310 is sufficiently filled, delivery        device 310 is activated to begin dispensing cleaning liquid to        application tray 100 via tube 312, one-way valve 314,        reciprocating flow controller 330, and tube 332.    -   3. Collection device 320 is activated sequentially to or        simultaneously with activation of delivery device 310 to begin        drawing cleaning liquid from application tray 100 via tube 334,        reciprocating flow controller 330, tube 322, and one-way valve        324. Cleaning solution will be prevented from flowing through        tube 372 by one-way flow valve 374. In some embodiments,        delivery device 310 and collection device 320 are controlled by        a logic circuit to work in concert so that an equal volumetric        flow of cleaning liquid is dispensed from delivery device 310        and drawn into collection device 320.    -   4. Collection device 320 is activated to begin dispensing        cleaning solution to cleaning liquid reservoir 370 via tube 376        and one-way valve 378. Cleaning liquid will be prevented from        flowing through tube 322 by one-way flow valve 324. Delivery        device 310 is also activated to begin drawing cleaning liquid        from cleaning liquid reservoir 370 through tube 372 and one-way        flow valve 374.    -   5. To reciprocate the cleaning liquid, steps 2 and 3 are        repeated after the flow direction is reversed, cycling cleaning        liquid between delivery/collection device 320 and application        tray 100, using tubes 334 and 332, respectively.    -   6. To cycle cleaning liquid, steps 2 through 4 are repeated,        cycling cleaning liquid between cleaning liquid reservoir 370        and application tray 100    -   7. The process continues to run until the time required for        cleaning has expired, or the desired numbers of cycles are        complete.

FIG. 3 is a schematic drawing of a second alternative embodiment of asystem according to the present invention. The figure shows system 400,with components including: means for providing reciprocation of liquidsin the oral cavity 402, liquid reservoir 470, liquid supply reservoir490, and means for directing the liquid onto the plurality of surfacesof the oral cavity, in this instance shown as application tray 100.Means for providing reciprocation 402 may include delivery device 410,collection device 420, optional reciprocating flow controller 430, tubes412, 422 a, 422 b, 472, 476, and 492, and solution one-way flow valves414, 424 a, 424 b, 474, 478, and 494. Tubes 432 and 434 provide forconveyance of the liquid from reciprocating flow controller 430 toapplication tray 100.

In the present embodiment, delivery device 410 and collection device 420are housed together as a duel action piston pump, with common piston415. Liquid supply reservoir 490 and liquid reservoir 470, may be madeof glass, plastic, or metal. Liquid supply reservoir 490 may be integralto system 400 and refillable. In some embodiments, liquid supply chamber490 may be a replaceable liquid supply, detachably connected to system400.

In some embodiments, any of liquid supply chamber 490, liquid reservoir470, or tubes 412, 472, 492, may include a heat source to pre-warmcleaning solution prior to direction into application tray 100 forapplication to the teeth. The temperature should be maintained within arange effective to provide comfort to the user during use.

Application tray 100 could be integral with, or detachably connected toreciprocating means 402 by way of tubes 432, 434 and other attachmentmeans (not shown).

Liquid in liquid supply chamber 490 flows through tube 492 to liquidreservoir 470. Liquid in reservoir 470 flows through tube 472 todelivery device 410. Liquid flow through tube 472 is controlled byone-way flow valve 474. From delivery device 410, liquid flows throughtube 412 to reciprocating flow controller 430. One-way flow valve 414controls the liquid flow through tube 412. Liquid flows fromreciprocating flow controller 430 to application tray 100 through tube432 or tube 434, depending on the flow direction. Liquid flows fromapplication tray 100, through tube 434 or tube 432, again depending onthe flow direction, back to reciprocating flow controller 430, and fromreciprocating flow controller 430 to collection device 420, throughtubes 422 a and 422 b. One-way flow valves 424 a and 424 b control theliquid flow through the tubes. Finally, liquid flows from collectiondevice 420 to liquid reservoir 470 through tubes 476 a and 476 b.One-way flow valves 478 a and 478 b control the liquid flow through thetubes.

The actions of delivery device 410 and collection device 420 arecontrolled by a logic circuit, which may include a program to the startreciprocation cycle, a program to execute the reciprocation cycle, i.e.to cause solution to be reciprocated about the plurality of the surfacesof the oral cavity, thereby providing the beneficial effect, a programto empty application tray 100 at the end of the cycle, and aself-cleaning cycle to clean the system between uses, or at pre-set orautomatic cleaning times.

System 400 may also include switches such as on/off, fill applicationtray 100, execute cleaning process, empty system 400, and clean system400, and indicator, or display, lights including, but are not limitedto, power on, charging, reciprocation program running, device emptying,and self-cleaning cycle in operation. In embodiments where liquid ispre-warmed prior to direction into application tray 100, a display lightcould be used to indicate that the liquid is at the proper temperaturefor use.

One method of using system 400 to clean teeth is as follows. Prior touse, cleaning liquid in liquid supply reservoir 490 flows through tube492 and one-way valve 494 to cleaning liquid reservoir 470. In someembodiments, liquid supply reservoir 490 is now disconnected from system400.

In the first step, the user positions application tray 100 in the oralcavity about the teeth and gingival area. The user bites down on tray100, thereby achieving an effective fit or seal between gums, teeth andtray 100. The user pushes a start button initiating the cleaningprocess. The cleaning process is as follows:

-   -   1. Piston 415 is activated to begin drawing cleaning liquid to        delivery device 410 from cleaning liquid reservoir 470 through        tube 472 and one-way flow valve 474. To accomplish this, piston        415 translates from right to left (“R” to “L” on FIG. 3).    -   2. Once delivery device 410 is sufficiently filled, delivery        device 410 is activated to begin dispensing cleaning liquid to        application tray 100 via tube 412, one-way valve 414,        reciprocating flow controller 430, and tube 432. To accomplish        this, piston 415 translates from left to right (“L” to “R” on        FIG. 3). The “L” to “R” motion of piston 415 causes collection        device 420 to begin drawing cleaning liquid from application        tray 100 via tube 434, reciprocating flow controller 430, tube        422 a, and one-way valve 424 a. Cleaning liquid will be        prevented from flowing through tubes 472 and 422 a, by one-way        flow valves 474 and 424 b. Any excess cleaning liquid in        collection device 420 will begin dispensing to cleaning liquid        reservoir 470 via tube 476 b and one-way valve 478 b. Cleaning        liquid will be prevented from flowing through tube 422 b by        one-way flow valve 424 b.    -   3. To cycle cleaning solution, steps 1 and 2 are repeated,        cycling cleaning liquid between cleaning solution reservoir 470        and application tray 100    -   4. The process continues to run until the time required for        cleaning has expired, or the desired numbers of cycles are        complete.

Each embodiment described in FIG. 1, FIG. 2, and FIG. 3 may includereciprocating flow controller (230, 330, 430 in FIG. 1, FIG. 2, FIG. 3,respectively). A perspective drawing and an exploded view of anembodiment of a reciprocating flow controller according to the presentinvention is shown in FIG. 6a and FIG. 6b , respectively. The figuresshow reciprocating flow controller 500 with housing 510 and flowdiverter 520. Housing 510 has ports 514, 515, 516, and 517. Flowdiverter 520 occupies the space defined by the inner walls of housing510, and has panel 522 for diverting liquid flow, and position adjuster524.

A perspective drawing and an exploded view of an alternate embodiment ofa reciprocating flow controller according to the present invention isshown in FIG. 4a and FIG. 4b , respectively. The figures showreciprocating flow controller 710 with cap 720, flow diverter disk 730,and base 740. Cap 720 has cap ports 722 and 724. Base 740 has base ports742 and 744. Flow diverter disk 730 is disposed between cap 720 and base740, and has panel 735 for diverting liquid flow, and position adjuster732 in the form of a gear.

FIG. 4c is a top view of reciprocating flow controller 710 in its firstposition. In this position, incoming liquid, such as liquid in tube 212of FIG. 1, enters reciprocating flow controller 710 through base port742. The liquid exits reciprocating flow controller 710 through cap port722, such as liquid in tube 232 of FIG. 1. Returning liquid, such asliquid in tube 234 of FIG. 1, reenters reciprocating flow controller 710through cap port 724. The liquid exits reciprocating flow controller 710through base port 744, such as liquid in tube 216 of FIG. 1.

FIG. 4d is a top view of reciprocating flow controller 710 in its secondposition. In this position, incoming liquid, such as liquid in tube 212of FIG. 1, enters reciprocating flow controller 710 through base port742. The liquid exits reciprocating flow controller 710 through cap port724 such as liquid in tube 234 of FIG. 1. Returning liquid, such asliquid in tube 232 of FIG. 1, reenters reciprocating flow controller 710through cap port 722. The liquid exits reciprocating flow controller 710through base port 744, such as liquid in tube 216 of FIG. 1.

Reciprocation of liquid in application tray 100 of FIG. 1 is achieved byswitching reciprocating flow controller 710 between its first and secondpositions. It has been found that the width of panel 735 relative to thediameters of cap ports 722 and 724 and base ports 742 and 744 iscritical to the performance of reciprocating flow controller 710. If thewidth of panel 735 is equal to or greater than any of the diameters,then one or more of cap ports 722 and 724 or base ports 742 and 744 maybe blocked, or isolated, during part of the reciprocation, resulting insuboptimal performance or device failure. A channel may be located inpanel 735 to avoid this condition.

The oral hygiene system may be comprised of several major componentsincluding, but not limited to, a base station, a hand piece forcontaining means for providing reciprocation of liquid about theplurality of surfaces within the oral cavity, and the application tray,or mouthpiece. The system is suitable for in-home use and adapted todirect liquid onto a plurality of surfaces of a tooth simultaneously.The device cleans teeth and removes plaque using cleaning solution thatis reciprocated back and forth creating a cleaning cycle and minimizingcleaning solution used. The device could be hand held, or may be in theform of a table or counter-top device.

The base station will charge a rechargeable battery in the hand piece,hold liquid reservoirs, house diagnostic components, provide feedback tothe user, and potentially clean the mouthpiece.

The hand piece will have a powered pump that will deliver liquid fromthe reservoir to the mouthpiece. The direction of flow may bereciprocated with liquid control valving, by a specialized pump(reversing its direction, etc), reversible check valves, or othersimilar means. The cycle time and flow velocity for each stage of thecycle will be variable and in some embodiments, be customized to eachindividual user. The hand piece will perform a filling process, and acleaning and/or purging process. The hand piece and/or base station mayprovide feedback to the user for each stage of the process andpotentially report diagnostic information.

The hand piece will be aesthetically pleasing and have a grip/feelcomfortable for the user's hand. The weight and balance will be wellsuited to comfortable and efficient use while giving a high qualityfeel. Finger grips and/or touch points will be appropriately located forcomfort, grip, feel, and assistance in proper orientation and griplocation of the hand piece. The base station will also be aestheticallypleasing and allow the hand piece to easily and securely dock intoposition. The base station may or may not lock the hand piece intoposition once it's docked.

FIG. 5 is a top perspective view of a first embodiment of means fordirecting liquid onto a plurality of surfaces in the oral cavity, e.g.an application tray 100, according to the present invention. FIG. 6 is abottom perspective view of the application tray 100 of FIG. 5. Thefigures show application tray 100 with outer front wall 112, outer backwall 114, inner front wall 116, inner back wall 118, and base membrane,e.g. bite plate, 156. Inner front wall jet slots 132 are located oninner front wall 116, while inner back wall jet slots 134 are located oninner back wall 118. The inner front wall jet slots 132 and inner backwall jet slots 134 shown in FIGS. 5 and 6 are only one embodiment of jetslot configuration. First port 142 and second port 144 enter applicationtray 100 through outer front wall 112.

FIGS. 5 and 6 depict an embodiment of an application tray 100 in whichthe user's top and bottom teeth and/or gingival area are substantiallysimultaneously contacted with liquid to provide the desired beneficialeffect. It should be understood that in other embodiments, applicationtray 100 may be designed to clean and/or treat only the top or bottomteeth and/or gingival area of the user.

FIGS. 7 and 8 are vertical and horizontal, respectively, sectional viewsof the application tray 100 of FIG. 5. The figures show first manifold146, defined as the space bordered by outer front wall 112 and innerfront wall 116. Second manifold 148 is defined as the space bordered byouter back wall 114 and inner back wall 118. The liquid-contactingchamber (LCC) 154 is defined by inner front wall 116, inner back wall118, and base membrane 156.

In one embodiment of an operation, liquid enters first manifold 146through first port 142 by pressure and then enters LCC 154 through innerfront wall jet slots 132. A vacuum is pulled on second port 144 to pullthe liquid through inner back wall jet slots 134, into second manifold148 and finally into second port 144. In this embodiment, jets of liquidare first directed onto the front surfaces of the teeth and/or gingivalarea from one side of the LCC 154, directed through, between, and aroundthe surfaces of the teeth and/or gingival area from the other side ofLCC 154 into the second manifold to provide controlled interdental,gumline, surface and/or gingival area cleaning or treatment. Next, theflow in the manifolds is reversed. Cleaning liquid enters secondmanifold 148 through second port 144 by pressure and then enters LCC 154through inner back wall jet slots 134. A vacuum is pulled on first port142 to pull the liquid through inner front wall jet slots 132, intofirst manifold 146 and finally into first port 142. In the secondportion of this embodiment, jets of liquid are directed onto the backsurfaces of the teeth and/or gingival area, and directed through,between, and around the surfaces of the teeth and/or gingival area. Thealternating of pressure/vacuum through a number of cycles creates aturbulent, repeatable and reversible flow to provide reciprocation ofliquid about the plurality of surfaces of the oral cavity tosubstantially simultaneously contact the surfaces of the oral cavitywith liquid, thereby providing the desired beneficial effect.

In another embodiment it may be preferable to deliver the liquid throughone or both manifolds simultaneously, flooding LCC 154, submerging theteeth for a period of time and then evacuating the LCC 154 after a setperiod of time through one or both manifolds. Here, cleaning or treatingliquid simultaneously enters first manifold 146 through first port 142,and second manifold 148 through second port 144 by pressure and thenenters LCC 154 simultaneously through inner front wall jet slots 132 andinner back wall jet slots 134. To evacuate LCC 154, a vacuum issimultaneously pulled on first manifold 146 through first port 142, andsecond manifold 148 through second port 144. Cleaning or treatmentliquid is pulled through inner front wall jet slots 132 and inner backwall jet slots 134, into first manifold 146 and second manifold 148.

It is also possible to deliver different liquid compositions to firstmanifold 146 and second manifold 148. The different liquid compositionscould then combine in the LCC for improved cleaning efficacy ortreatment effects.

FIG. 9 is a top, rear perspective view of a second embodiment of anapplication tray 1100 according to the present invention. FIG. 10 is atop, front perspective view of the application tray 1100 of FIG. 9,while FIG. 11 is a top view of the application tray of FIG. 9. Thefigures show application tray 1100 with top piece 1102, bottom piece1104, first port 1142, second port 1144, and support plate 1108 fixedlyattached to the front of said application tray. First port 1142 andsecond port 1144 enter application tray 1100 and extend through supportplate 1108. FIG. 11 also shows optional sensing means 1152 whichdetermines if the mouthpiece is in the correct position over the teethin the oral cavity.

Optional quick disconnect structures, e.g. barbs, 1110 are attached tosupport plate 1108, allowing application tray 1100 to be quickly andeasily attached to and then disconnected from means for providing liquidto the application tray. The housing would include structure effectiveto receive such quick disconnect barbs, or similar quick disconnectstructure, in attachable engagement, to detachably connect theapplication tray to the housing. The quick disconnect option could beused to replace used or worn application trays, or to change applicationtrays for different users. In some embodiments, a single user may changeapplication trays to change the flow characteristics for differentoptions, such as number of cleaning nozzles, nozzle velocity, spraypattern, and locations, coverage area, etc.

FIGS. 9 to 12 depict an embodiment of an application tray 1100 in whichthe user's top and bottom teeth and/or gingival area are substantiallysimultaneously contacted with liquid. It should be understood that inother embodiments, application tray 1100 may be designed to contact onlythe top or bottom teeth or gingival area of the user with liquid.

Top piece 1102 has front liquid lumens 1102 a, 1102 b, 1102 c, and 1102d, back liquid lumens 1102 e, 1102 f, and 1102 g, first manifold 1146,second manifold 1148, base membrane 1156, and back gum-sealing membrane1158. Front liquid lumens 1102 a, 1102 b, 1102 c, and 1102 d are allconnected by first manifold 1146, and optionally (as shown on FIGS. 9 to12), connected to each other along all, or part of, their length.Likewise, back liquid lumens 1102 e, 1102 f, and 1102 g, are allconnected by second manifold 1148, and optionally, connected to eachother along all, or part of, their length.

Bottom piece 1104, may be a mirror image of top piece 1102, and hasfront liquid lumens 1104 a, 1104 b, 1104 c, and 1104 d, back liquidlumens 1104 e, 1104 f, and 1104 g, first manifold 1146, second manifold1148, base membrane 1156, and back gum-sealing membrane 1158. Frontliquid lumens 1104 a, 1104 b, 1104 c, and 1104 d are all connected byfirst manifold 1146, and optionally (as shown on FIGS. 9 to 12),connected to each other along all, or part of, their length. Likewise,back liquid lumens 1104 e, 1104 f, and 1104 g, are all connected bysecond manifold 1148, and optionally, connected to each other along all,or part of, their length.

Though FIGS. 9 and 12 show top piece 1102 with four front liquid lumens(1102 a, 1102 b, 1102 c, and 1102 d) and three back liquid lumens (1102e, 1102 f, and 1102 g), top piece 1102 may also be formed with two,three, five, six, or even seven front or back liquid lumens. Likewise,bottom piece 1104 is shown with four front liquid lumens (1104 a, 1104b, 1104 c, and 1104 d) and three back liquid lumens (1104 e, 1104 f, and1104 g), bottom piece 1104 may also be formed with two, three, five,six, or even seven front or back liquid lumens.

The liquid-contacting chamber ((LCC) 1154 a, mentioned above, is locatedin top piece 1102, defined by front liquid lumens (1102 a, 1102 b, 1102c, and 1102 d), back liquid lumens (1102 e, 1102 f, and 1102 g), basemembrane 1156, and back gum-sealing membrane 1158. Though not shown,bottom piece 1104 also has a LCC 1154 b, defined by front liquid lumens(1104 a, 1104 b, 1104 c, and 1104 d), back liquid lumens (1104 e, 1104f, and 1104 g), base membrane 1156, and back gum-sealing membrane 1158.

The multi-lumen design provides bidirectional or dedicated lumens forflow and vacuum that are self-reinforcing and therefore do not collapseunder vacuum or rupture under pressure while in use, maximizing thestructural integrity, while minimizing the size of the overallapplication tray 1100 for user comfort during insertion, in-use, andupon removal. This decreased size also serves to provide an enhancedeffective seal of the application tray in the oral cavity.

If the multiple lumens (1102 a, 1102 b, 1102 c, 1102 d, 1102 e, 1102 f,1102 g, 1104 a, 1104 b, 1104 c, 1104 d, 1104 e, 1104 f, and 1104 g) areconnected as described above, they form a lumen hinge sections (1103 onFIG. 10). This may result in the multi-lumen design providingconformance in the X, Y and Z directions, due to the flexibility oflumen hinge sections 1103 between each lumen. This design allowseffective and feasible conformance to a variety of different users teethand gum topography, providing the effective gum sealing withoutirritating the gums and allowing dynamic positioning of the liquidcleaning jets around each of the teeth to obtain proximal andinterdental cleaning action. The multiple lumens are also attached tothe first manifold 1146 and second manifold 1148. This creates asecondary flexible joint providing two additional degrees of motion forthe adjusting to different bite architectures that may be encountered.

The back gum-sealing membrane 1158 proves a flexible and universalsealing mechanism to minimize leakage into the oral cavity whileredirecting flow onto and around teeth, to maximize treatment/cleaningarea to get to hard-to-reach-places (HTRP). The membrane can provide anelastic function across the lumen longitudinal axis to form around theteeth and gums.

Base membrane 1156 provides the flexibility required for effective fitor sealing within the oral cavity and allowing redirection and flow ofjets back towards the teeth and/or gingival surfaces.

Optionally, application tray 1100 could also include gum-sealingcomponent if required, which could be attached to the front liquidlumens 1102 a, 1102 b, 1104 a, and 1104 b, and back liquid lumens 1102 eand 1104 e (member furthest from teeth).

Optionally, frictional elements, such as filament tufts, could also beplaced or secured through any of the lumen hinge sections 1103 withoutsignificantly increasing the size of application tray 1100, or impactinguser comfort or liquid flow in the application tray 1100.

Inner front wall jet slots 1132 are located on inner front wall of toppiece 1102 and bottom piece 1104, while inner back wall jet slots 1134are located on inner back wall of top piece 1102 and bottom piece 1104.Though only one inner front wall jet slot 1132 and inner back wall jetslot 1134 are shown in FIGS. 9 to 12, the number, shape and size ofinner front wall jet slots 1132 and inner back wall jet slots 1134affect the cleaning of the teeth and gums, and can be designed to directjets of cleaning liquid in a variety of spray patterns. The inner frontwall jet slots 1132 and inner back wall jet slots 1134 shown in FIGS. 9to 12 are only one embodiment of jet slot configuration.

FIGS. 9 and 10 depict an embodiment of an application tray 1100 in whichsurfaces of the users top and bottom teeth and/or gingival area aresubstantially simultaneously contacted by liquid to provide the desiredbeneficial effect. It should be understood that, in other embodiments,application tray 1100 may be designed to contact only the top or bottomteeth and/or gingival area of the user.

FIG. 12 is a cut-away view of the application tray 1100 of FIG. 9. Thefigure shows first manifold 1146 and second manifold 1148. In oneembodiment of a cleaning operation, cleaning liquid is pumped throughfirst port 1142, and enters first manifold 1146 through first flowdiverter 1143. Liquid enters front liquid lumens 1102 a, 1102 b, 1102 c,1102 d, 1104 a, 1104 b, 1104 c and 1104 d through front liquid lumenports 1147. The cleaning liquid then enters LCCs 1154 a and 1154 bthrough inner front wall jet slots 1132. A vacuum is pulled on secondmanifold feeder 1144 to pull the cleaning liquid through inner back walljet slots 1134, into back liquid lumens 1102 e, 1102 f, 1102 g, 1104 e,1104 f, and 1104 g. The liquid enters second manifold 1148 through backliquid lumen ports 1149, then through second flow diverter 1145, andfinally into second manifold feeder 1144.

In this embodiment, jets of cleaning liquid are first directed fromfirst manifold 1146 to the front surfaces of the teeth and/or gingivalarea from one side of the LCCs, directed through, between, and aroundthe surfaces of the teeth and/or gingival area from the other side ofthe LCCs into the second manifold 1148 to provide controlledinterdental, gumline, surface and/or gingival area cleaning ortreatment.

Next, the flow in the manifolds is reversed. Cleaning liquid is pumpedthrough second port 1144, and enters second manifold 1148 through secondflow diverter 1145. Liquid enters back liquid lumens 1102 e, 1102 f,1102 g, 1104 e, 1104 f, and 1104 g through back liquid lumen ports 1149.The cleaning liquid then enters LCCs 1154 a and 1154 b through innerback wall jet slots 1134. A vacuum is pulled on first port 1142 to pullthe cleaning liquid through inner front wall jet slots 1132, into frontliquid lumens 1102 a, 1102 b, 1102 c, 1102 d, 1104 a, 1104 b, 1104 c and1104 d. The liquid enters first manifold 1146 through front liquid lumenports 1147, then through first flow diverter 1143, and finally intofirst port 1144.

In the second portion of this embodiment, jets of cleaning liquid aredirected onto the back surfaces of the teeth and/or gingival area, anddirected through, between, and around surfaces of the teeth and/orgingival area. The alternating of pressure/vacuum through a number ofcycles creates a turbulent, repeatable and reversible flow to providereciprocation of liquid about the plurality of surfaces of the oralcavity to substantially simultaneously contact the surfaces of the oralcavity with liquid, thereby providing the desired beneficial effect.

In another embodiment it may be preferable to deliver the liquid throughone or both manifolds simultaneously, flooding LLCs 1154 a and 1154 b,submerging the teeth for a period of time and then evacuating the LCCsafter a set period of time through one or both manifolds. Here, cleaningor treating liquid is simultaneously pumped through first port 1142 intofirst manifold 1146 via first flow diverter 1143, and through secondport 1144 into second manifold 1148 via second flow diverter 1145.Liquid then simultaneously enters front liquid lumens 1102 a, 1102 b,1102 c, 1102 d, 1104 a, 1104 b, 1104 c and 1104 d through front liquidlumen ports 1147, and back liquid lumens 1102 e, 1102 f, 1102 g, 1104 e,1104 f, and 1104 g through back liquid lumen ports 1149. The cleaningliquid then enters LCCs 1154 a and 1154 b through inner front wall jetslots 1132 and inner back wall jet slots 1134. To evacuate the LCCs, avacuum is simultaneously pulled on first manifold 1146 through firstport 1142, and second manifold 1148 through second port 1144. Cleaningor treatment liquid is pulled through inner front wall jet slots 1132and inner back wall jet slots 1134, into first manifold 146 and secondmanifold 148.

It is also possible to deliver different liquid compositions to firstmanifold 1146 and second manifold 1148. The different liquidcompositions would then combine in the LCC for improved cleaningefficacy or treatment effects. In the dual manifold design it may bepreferable to supply each manifold from a separate liquid supplyreservoir, such as in a dual action piston pump configuration, where onesupply line connects to supply first manifold 1146 and the other pistonsupply line provides and removes liquid from second manifold 1148, e.g.when one manifold is being supplied with liquid the second manifold isremoving liquid, and vice versa.

In other embodiments, valves can be placed at front liquid lumen ports1147 of front liquid lumens 1102 a, 1102 b, 1102 c, 1102 d, 1104 a, 1104b, 1104 c and 1104 d, or at back liquid lumen ports 1149 of back liquidlumens 1102 e, 1102 f, 1102 g, 1104 e, 1104 f, and 1104 g to provideimproved function by allowing lumens to engage at different times (atdifferent points in the cleaning/treatment cycle), at pulsed intervals.As an example, in one embodiment, not all lumens engage in the liquidpumping/vacuum function. Here, front liquid lumens 1102 a and 1104 a,and back liquid lumens 1102 e and 1104 e, which primarily engage thegums, only engage in the liquid vacuum function. This would help preventliquid from leaking into the oral cavity. Valving also allows forvariable flow, allowing a decreased resistance to the liquid vacuumfunction, or allowing increased pumping, and therefore liquid velocity,during liquid delivery.

In still other embodiments, individual inner front wall jet slots 1132or inner back wall jet slots 1134 may have integrated one-way valves,such as duckbill valves or umbrella valves, to allow flow only in onedirection out of those particular jets. This may be effective toincrease vacuum relative to pressure/delivery in the LCC.

In some embodiment, the motion of the frictional elements discussedabove, relative to the teeth, could be applied by a single orcombination of mechanisms including, by not limited to, the liquid (viathe jet slots or via turbulence of flow); movement of the membrane viathe pulsing of the flexible application tray 1100; an externalvibrational mechanism to vibrate the frictional elements; linear and orrotational movement of the application tray 1100 around the teeththrough user jaw motion or external driving means.

In other embodiments, a conformable substance, such as gel, may bedisposed near the back gum-sealing membrane 1158, allowing applicationtray 1100 to comfortably fit against the back of the mouth.Alternatively, the end of application tray 1100 may have a mechanism orattachment to extend or decrease the length of the mouthpiece to theproper length for each individual user, providing a semi-custom fit.

Manufacturing of the multi-lumen design is feasible utilizing existingavailable manufacturing and assembly processes such as extrusion,injection, vacuum, blow, or compression molding. Other feasibletechniques include rapid prototyping techniques such as 3D printing andother additive techniques, as well as subtractive techniques.

The application tray may be custom manufactured for each individualuser, or customizable by the individual user prior to use. For custommanufacture of the application tray, vacuum form molds can be createddirectly or indirectly from user teeth and gingival impressions, whichcreate a model of the teeth which can then be modified to createrequired clearances and flow channels. These vacuum form molds can becreated at low cost utilizing CAD and rapid prototyping processes.

One manufacturing method is to create individual component shellsthrough vacuum forming. Low cost methods allow vacuuming forming of verythin wall structures. The component geometry is designed to provide theinterlocking features and structural geometry to allow minimization ofthe size of the application tray. When assembled, the manufacturedcomponents form the necessary manifolds and flow structure(bidirectional and/or dedicated manifolds) to provide the requiredperformance characteristics for treating/cleaning the teeth.

Customized mouthpieces are based on the user's teeth geometry, thereforecreating a consistent distance between the mouthpiece and teeth mayprovide a more consistent cleaning/treating experience. The materialsfor each of the two-piece shell may be different, therefore allowing forsofter material (on the inside shell) where it contacts teeth/gums andharder material on the outside shell to maintain rigidity and theoverall shape.

For customizable application trays, tray pre-forms (similar to sportmouth guards or teeth grinding appliances) containing pre-manufacturedmanifolds, nozzles and channels are mass manufactured. The traypre-forms can be created through a variety of known manufacturingtechniques including, but not limited to, blow molding, vacuum forming,injection and/or compression molding. The material used in the pre-formwould be a low temperature deformable plastic material. The pre-formwould be used in conjunction with required spacers to be applied overthe teeth to provide required clearance, cleaning and/or treatmentperformance. Once the clearance components are applied to the teeth, thepre-form would be heated via microwave or by placing in boiling water soas to be pliable. The pliable pre-form would be applied onto the user'steeth and gingival area to create the customized application tray.

The application tray can be integrated with stressing features to allowelastic conformance to maximize positioning, comfort and performanceduring application and in use. For example, spring-like elements such asshins, clips and elastic bands may provide fitting over and againstgums.

Materials for the MP lumen could range from lower durometer flexiblematerials (25 shore A) to harder materials more rigid materials (90shore A), preferably being between 40 and 70 shore A.

Materials could be silicone, thermoplastic elastomer (TPE),polypropylene (PP), polyethylene (PE), polyethylene terephthalate (PET),ethylene vinyl acetate (EVA), polyurethane (PU), or multi-component(combination of materials and hardness) to achieve desired design andperformance attributes.

The jet openings or slots could be made through a secondary operationsuch as drilling or punching, or formed during molding. Alternatively,the jet openings or slots could be inserted into the application tray toprovide increased wear and or different jet performance characteristics,and could be combined with frictional cleaning elements or othercomponents to enhance the cleaning and/or treatment affect.

FIGS. 13 to 16 depict an embodiment of an application tray 1200 in whichonly the user's top or bottom teeth and gingival area are contacted withliquid. It should be understood that in other embodiments, applicationtray 1200 may be designed to substantially simultaneously contact boththe top and bottom teeth and gingival area of the user, as depictedelsewhere herein.

FIG. 13 is a top front perspective view of a third embodiment of anapplication tray 1200 according to the present invention. FIG. 14 is atop back view of the embodiment of the application tray 1200 of FIG. 13,while FIG. 15 is a bottom back view of the application tray 1200 of FIG.13. The figures show application tray 1200 with outer front wall 1212,outer back wall 1214, inner front wall 1216, and inner back wall 1218.Inner front wall jet slots 1232 are located on inner front wall 1216,while inner back wall jet slots 1234 are located on inner back wall1218. First port 1242 and second port 1244 enter application tray 1200through outer front wall 1212.

The number and location of inner front wall jet slot 1232 and inner backwall jet slot 1234 as shown in FIGS. 13 to 16 is exemplary and is notintended to limit the scope of the application tray. The actual number,shape and size of inner front wall jet slots 1232 and inner back walljet slots 1234 affect the cleaning of the teeth and gums, and can beselected or designed to direct jets of cleaning liquid in a variety ofspray patterns. The inner front wall jet slots 1232 and inner back walljet slots 1234 shown in FIGS. 13 to 16 are only one embodiment of jetslot configuration.

FIG. 16 is a vertical sectional view of the application tray 1200 ofFIG. 13. The figures show first manifold 1246, defined as the spacebordered by outer front wall 1212 and inner front wall 1216. Secondmanifold 1248 is defined as the space bordered by outer back wall 1214and inner back wall 1218. The liquid contact chamber (LCC) 1254 isdefined by inner front wall 1216, inner back wall 1218 and inner basewall 1250.

In one embodiment of a cleaning operation, cleaning liquid enters firstmanifold 1246 through first port 1244 by pressure and then enters LCC1254 through inner front wall jet slots 1232. A vacuum is pulled onsecond port 1242 to pull the cleaning liquid through inner back wall jetslots 1234, into second manifold 1248 and finally into second port 1244.In this embodiment, jets of cleaning liquid are first directed onto thefront side of the teeth from one side of the LCC, directed through,between, and around the teeth from the other side of the LCC into thesecond manifold to provide controlled interdental, gumline, surfaceand/or gingival area cleaning. Next, the flow in the manifolds isreversed. Cleaning liquid enters second manifold 1248 through secondport 1242 by pressure and then enters LCC 1254 through inner back walljet slots 1234. A vacuum is pulled on first port 1244 to pull thecleaning liquid through inner front wall jet slots 1232, into firstmanifold 1246 and finally into first port 1244. In the second portion ofthis embodiment, jets of cleaning liquid are directed onto the back sideof the teeth, and directed through, between, and around the teeth and/orgingival area. The alternating of pressure/vacuum through a number ofcycles creates a turbulent, repeatable and reversible flow, therebyproviding reciprocation of liquid over and about the surfaces of theoral cavity.

In another embodiment of a cleaning, treatment, pre-treat, or post treatoperation, it may be preferable to deliver the liquid through one orboth manifolds simultaneously, flooding LCC 1254, submerging the teethfor a period of time, and then evacuating the chamber after a set periodof time through one or both manifolds. Here, cleaning or treating liquidsimultaneously enters first manifold 1246 through first port 1244, andsecond manifold 1248 through second manifold feeder 1242 by pressure andthen enters mouthpiece space 1254 simultaneously through inner frontwall jet slots 1232 and inner back wall jet slots 1234. To evacuate theLCC, a vacuum is simultaneously pulled on first manifold 1246 throughfirst port 1244, and second manifold 1248 through second port 1242.Cleaning liquid is pulled through inner front wall jet slots 1232 andinner back wall jet slots 1234, into first manifold 1246 and secondmanifold 1248. It is also possible to deliver different liquidcompositions to first manifold 1246 and second manifold 1248. Thedifferent liquid compositions would then combine in the LCC for improvedcleaning efficacy. In the dual manifold design it may be preferable tosupply each manifold from a separate chamber, such as in a dual actionpiston pump configuration, where one supply line connects and to supplyfirst manifold 1246 and the other piston supply line provides andremoves from second manifold 1248 (when one manifold is being suppliedthe second manifold is removing and vice versa).

Gingival Seal

The gingival seal forms the bottom portion of the LCCM and contacts withthe gingival tissue in such a way as to clean the gingival area,including the sub-gingival pocket. In one embodiment, it providespositioning of the mouthpiece relative to the oral cavity and teeth, andcreates a relatively isolated environment with minimal/acceptableleakage during operation, while designed to minimize the gag factor andcomfort for the user. In one embodiment, the gingival seal is created bythe frictional engagement and compression of an elastomeric materialwith the gingival. This seal is enhanced during the evacuation of theliquid within and during the cleaning and treatment cycles. The sealalso functions as a secondary mechanism for attaching and assembling themanifold and LCCM. The size and shape of the gingival or gum sealpreferably utilizes three basic sizes (small, medium and large), but isdesigned to allow different levels of customization as required by theuser for comfort and cleaning/treatment efficacy. These sizes are pairedwith the three basic sizes of the manifold and LCCM components.

Alternate embodiments for obtaining the gingival seal include thefollowing and may be used in combination with each other or with theembodiment above:

Embodiment #1

-   -   The mouthpiece is positioned within the oral cavity and onto the        gingival. The seal and position is fixed relative to the teeth        and gingival when slight biting pressure is applied against the        bite standoffs/locating blocks. The mouthpiece would be made out        of a single or combination of materials of different hardness        and resilience. In the preferred embodiment, the “H” shaped        mouthpiece would have flexible walls (vertical edges of the “H”)        which would have a soft, resilient gasket-like material (closed        cell silicone, gel filled seal, etc.) at the ends of each of the        “H” legs. The horizontal pad of the “H” would include biting        blocks/standoffs for positioning the mouthpiece in the X, Y,        and/or Z locations, relative to the teeth and gingival. Once the        mouthpiece is positioned in the oral cavity, closing of the        upper and lower jaw to engage the bite blocks would provide        positive and rigid positioning of the mouthpiece relative to the        oral cavity, while providing interference of the gasket-like        material with the gingival material to provide an effective seal        and formation of the cleaning, treatment, and/or diagnostic        cavity for the duration of the operation.

Embodiment #2

-   -   Force applied to the mouthpiece to create inward movement of        sidewalls, sealing a soft resilient edge against the gingival        tissue. A mouthpiece similar to that described in embodiment #1        would also provide an active locking feature to improve the        engagement of the seal. One potential execution of this would        require that a hollow section be designed within the horizontal        leg and between some or all of the standoffs between the upper        and lower sections of the mouthpiece, when the device is not        engaged. After the mouthpiece is placed in the oral cavity, the        user bites down and compresses the hollow section, which then        collapses so that all the bite blocks are in contact. This in        turn causes the external walls (the vertical leg portions) to        fold inwardly towards the gingival tissue. The resilient gasket        attached to these walls engages and compresses against the        gingival to create the seal and the cleaning, diagnostic, and/or        treatment chamber surrounding the upper and lower teeth.

Embodiment #3

-   -   A pneumatic bladder is inflated or pressurized when the        mouthpiece is positioned in the oral cavity to create the seal        and cavity with the gingival. A mouthpiece similar to that        described in embodiment #1 could also provide an active seal        through the inflation of a bladder, or bladders, within the        mouthpiece. The air could also subsequently be utilized to clean        and or dry the teeth/cavity and/or provide treatment (gas and or        entrained particle in gas) for treatment, cleaning and/or        diagnostics.

Embodiment #4

-   -   A hydraulic bladder is inflated or pressurized when the        mouthpiece is positioned in the oral cavity to create the seal        and cavity with the gingival. A mouthpiece similar to that        described in embodiment #1 could also provide an active seal        through the pressurization of a bladder(s) within the        mouthpiece. The liquid composition could also subsequently be        utilized to clean and/or treat the teeth and or gingival tissue        with or without gas or entrained particles for cleaning,        treatment, or diagnostics.

Embodiment #5

-   -   After the mouthpiece is positioned in the oral cavity, the seal        is created through a change in compliance of the material        engaging the gingival with or without expansion of the material        to seal around the gingival due to liquid absorption (utilize a        hydrogel, etc.).

Embodiment #6

-   -   After the mouthpiece is positioned in the oral cavity, Nitanol        wire or other shape-memory materials embedded into the        mouthpiece cause the side walls to engage the gingival due to        the change of body temperature in the oral cavity, creating a        positive seal with the gingival tissue.

Embodiment #10

-   -   A foam-like material is extruded into the mouthpiece area        initially or alternatively during each use to create the        mouthpiece seal and subsequent cleaning, treatment, and        diagnostic cavity.

Embodiment #11

-   -   A disposable or dissolvable insert is provided to provide the        seal to the gingival tissue for multiple or each use of the        mouthpiece.

Embodiment #12

-   -   An adhesive is contained on the gum seal contact surface, which        can be saliva or water activated. Adhesive would provide        potential seal improvement and could be single use or multiple        use application, depending on the formulation. Sealing system        can be used with any combination of other sealing systems        discussed.

Embodiment #13

-   -   The gingival seal is created through a combination of material        on contact area and geometry at the interface that creates a        suction-like effect in the seal contact area (suction cup)        through creation of a vacuum in this area during the engagement.

Embodiment #14

-   -   The gingival seal area can be made and customized to a user's        mouth by utilizing a deformable material that can be placed and        positioned against the gingival, which then takes on a permanent        set for the user. This may be created through boiling and        placing in the mouth and pressing against the gingival by        closing the jaw and or like method, then removing from the oral        cavity (similar to a mouth guard). As the sealing material        cools, it takes on a permanent set.

Embodiment #15

-   -   The gingival seal area can be created by taking a generic or        semi generic bladder and placing into the oral cavity in close        proximity to the desired gingival seal contact area. This        bladder can then be filled and directionally supported to engage        and conform against the gingival. The filling material would be        a fast curing material, which would take set to provide the        customized sealing form, which would then be reusable by this        specific user. The bladder could be a TPE and/or thin silicone        based material, and the filling material could be an RTV, epoxy,        polyurethane or similar material to provide a rigid, semi rigid        or flexible permanent set form when cured or set.

In a preferred embodiment, the gingival effective seal is a contact sealcreated by the geometry of the LCCM bottom edge engaging the gingiva.The LCCM bottom edge is preferably flexible to allow conformance todifferent user's gingival surfaces below the gum line and along thepoints of contact. This portion also needs to be soft enough so as notto cause abrasion or damage to the gingival region to provide comfort tothe user, while maintaining an effective seal. In the preferredgeometry, the LCCM contact area provides a radial and or curved smoothsurface to provide point of contact and a comfortable sealing. Thepreferred material of this edge would be a low durometer silicone, under100 Ra, and more preferably between 15 Ra and 70 Ra, due to itsdurability and inherent performance characteristics, but could also besoft and/or flexible materials, such as TPE's and other materials knowin the art.

The effective seal is formed in conjunction with the operation of thevacuum and removal of fluid from the LCC, allowing any residual leakagefrom the universal appliance to be pulled back into the LCC and the handheld device for subsequent removal.

Components

The entire system will be modular in nature so individual components canbe easily replaced by the user. Reasons for replacement include but arenot limited to wear, malfunction, and biohazard. Some components mayalso be disposable and replaceable by nature (refill cartridges, etc),thus modular and easily replaced by the user.

Pump System

In one embodiment, the liquid may be delivered from a reservoir in themouthpiece handle or base station via powered pump. The pump may becapable of responding to input from a logic system (artificialintelligence, or AI) to vary pressure, cycle time (for each stage andtotal process), reciprocating motion requirement and/or timing,direction of flow, liquid velocity/pressure, purge specifications, andsimilar. Though shown in FIG. 3 as a piston pump 420, the pump may be apiston pump, valveless rotary piston pump, diaphragm pump, peristalticpump, gear pump, rotary pump, double-acting piston pump, vane pump, orsimilar. A charged pneumatic cylinder or air compressor may also drivethe system as an alternative embodiment. The cycle time for the totalprocess, cycle time for each individual stage, and flow velocity foreach stage of the cycle may be variable and potentially customized toeach individual user/day of the week/oral health conditions. It is alsopossible to change the volume of liquid delivered per stroke or over atime period in different offerings of the system, depending on the needsof the specific user and specific treatment requirements. The pumpsystem may be in the hand piece or in the base station. The volume ofliquid per stroke of the piston pump may be relative large to give theeffect of pulses of liquid in the mouthpiece. An alternativelyembodiment has a pump that delivers constant flow with low or nopulsations. In the preferred embodiment, the forward stroke will deliverliquid to the mouthpiece through specified nozzles and the back strokewill create a vacuum to suck liquid through specific nozzles in themouthpiece back to the pump. The direction of the liquid to and from themouthpiece can be reversed by changing the direction of the motor in arotary valveless pump, directional valve, or other means. The liquiddrive system will not start until the mouthpiece is properly insertedand sealed against the gums. The system will automatically stopdispensing and may remove residual liquid from the mouth once themouthpiece is removed (effective seal against gums is broken) from themouth. This will allow the user to safely increase the concentrations ofactive ingredients in the cleaning/treatment formulation. The systemwill not start until the mouthpiece has an effective seals against thegums. In one embodiment the pump system is entirely contained in thehand piece, and in another the pump system is housed in the basestation.

In a preferred embodiment, the design will have a dual pistonarrangement to provide separate vacuum and delivery pumps, to allowsimultaneous vacuum and delivery of fluid from/to the LCC. The firstpiston would be for delivery/pressure, and can be configured for dualaction, delivering fluid both on the up and down strokes, but morepreferably single action, delivering fluid on the upstroke only. Thesecond piston would be the vacuum piston, which could be configured fordual or single action, but more preferably dual action to maintain anegative pressure in the LCC, and minimize residual leakage into theoral cavity from the LCC. The vacuum piston and total vacuum/volumetricremoval of fluid and air from the LCC is preferably greater than thevolumetric delivery of fluid to the LCC to ensure and effective seal ofthe LCC, minimizing residual fluid into the oral cavity. The ratio ofthe volumetric removal to delivery of fluid/air from the LCC is about10:1 or less, or about 3:1. The delivery and vacuum pistons can beoriented in a linear arrangement to minimize the cross-sectional area ofthe handle, or in a side-by-side arrangement to reduce overall length ofthe handle. They could be driven off the same piston rod to minimizedevice complexity/cost and be driven off the same drive motor.

It is preferred to utilize a unitary piston design without o-rings (withflared cupped edges), as this design reduces friction of the piston tocylinder by pulling back away from the cylinder in the non-performingdirection (down stroke for delivery), while expanding against thecylinder to provide improved efficiency when moving in the performingdirection (upstroke for delivery). The design also provides bettercompensation for wear of the pistons and cylinders due to its flexiblenature.

Valving/Liquid Control & Liquid Input/Output

It may be desirable to change the direction of the flow to themouthpiece if the mouthpiece embodiment is used wherein the mouthpiecehas one inlet and one outlet. The direction of liquid flow through theteeth would be reversed by changing the direction of flow of the inletand outlet to the mouthpiece, therefore increasing the efficacy andsensory affects of the cleaning process. The mouthpiece may have nozzleson opposite sides of the teeth wherein one side of the jets arepressured and the opposite side draws a negative pressure differential.This forces the liquid “through/between” the teeth. The flow is thenreversed on each set of nozzles to move the liquid the oppositedirection through the teeth. The liquid may then be reciprocated backand forth. The direction of flow may be reversed and/or reciprocated byreversing the direction of a specialized pump, such as a rotaryvalveless pump. Another embodiment includes but is not limited toreversible check valves, wherein the orientation of the check valves tothe pump is reversed, thereby reversing the direction of the flowthroughout the system. Another embodiment includes two controlling 3-wayvalves with the logic (AI) system to reverse the direction of flow whenactivated. A further embodiment has a logic (AI) system to onecontrolling 4-way valve with one input from the pump, a return to thepump, and two outlets to the mouthpiece that can reverse flow directionas desired. Another embodiment involves configuring tubing so as to shutoff of the flow with pinch valves to specific tubes in order to reversethe flow of the system. Another embodiment includes development of aliquid control switching box that connects two tubes on one side of thebox to two tubes on the opposite side of the box. In one orientation theliquid flow moves directly across the box from one collinear tube to thenext, while in the other position the liquid flow moves in an “X”direction whereby liquid flow direction is “crossed” in the switchingbox. In another embodiment, flow is reciprocated by using adouble-acting piston pump, wherein the flow is constantly reciprocatedback & forth between the two piston pump heads.

In one embodiment the liquid control system is entirely contained in thehand piece, and in another embodiment, the liquid control system ishoused in the base station. The tubing used in the system must withstandboth pressure and vacuum states.

One or more liquid types from individual reservoirs can be deliveredthrough the mouthpiece individually or combined. Any combination andconcentration variation can be used. The reservoirs may reside in thehand piece or in the base station.

The system may include manual and/or automatic air purging, and/or anaccumulator to provide system compressibility.

The valving system for directing and controlling fluid to and from thevacuum and delivery pumping systems may be optimized to provide amodular, cost effective, efficient system that allows for simplifiedmanufacturing and assembly. In addition, improved maintenance of thesystem can be achieved by using a cut sheet of flexible film sandwichedbetween two injection moldable components.

The switching/fluid reciprocation control system to create the fluidreciprocation can be mechanical (driven via mechanism/gearing orelectrical (electrically controlled valving such as multi-way solenoidflow valves, initiated via an electrical signal). In the preferredmechanical embodiment, the switching system is driven off the pump drivemotor(s), so as to minimize the size, complexity and cost of the overallsystem. This is completed via mechanical linkages and gearing as shownbelow, driving the unique switching mechanism. The switching mechanismcan be reciprocative in nature, such as a cam engaging a slide switchingmember, pushing it back and forth. It can also be a unique, continuousrevolving switching disk member as shown in the exploded andcross-sectional views below, switching fluid direction 2 times for everysingle rotation of the disk, due to the unique D-shaped flow channel.The design provides a built in pressure relief valve like function thatallows flow cross-over when switching flow directions, without anyadditional hardware, to minimize strain on the drive motor/system andincreasing life of the motor/system.

Interface (Electrical & Liquid)

The hand piece may have an electrical and/or communication system thatinterfaces with the base station. This includes but is not limited tocharging of the rechargeable battery, transferring diagnosticinformation between the units, transferring custom profile informationbetween the units, and transferring program-related information betweenthe units. Information can be transferred wirelessly (RFID, 802.11,infrared, etc.) or through a hard connection. The electrical system willinclude logic so as to control the function, start, and stop of thesystem based on preset criteria. The criteria may include starting onlyafter a seal has been created between the mouthpiece and the gums,ensuring a properly charged liquid system, ensuring a minimum batterycharge level, ensuring the liquid level is within a specified range,etc. There may be a logic system that may communicate with variouscomponents of the device including, but not limited to, initiatingalgorithms to control the sequencing of the valves, motion of the pistonand therefore motion of the liquid, receive inputs from the consumer,receive inputs from the temperature sensor, receive diagnostic input,detect engagement of the mouthpiece seal against the gums, etc. Thelogic system must be capable of processing and responding to an inputand outputting appropriate data. The system may include redundantcircuitry wherein providing a fail-safe design.

The system may include a means to provide feedback to the user such aslights, display, touch screen, recorded messages, vibration, sounds,smell, and similar. It may also have a means to operate the system andselect processes/settings, such as switches, touch screens, buttons,voice commands, and similar.

The system may include a means for tracking statistics such as timebetween uses, length of use/cycle, total uses, regimen details (amountand time of each liquid/treatment), time to replace specific systemcomponents, and similar. The system may provide feedback to the user toindicate time to replace or refill, wear, disposable, or replaceablecomponents.

There will be a method of liquid supply, which may be a liquidreservoir, hose supply system, or similar. The liquid supply may belocated in the base station and transferred to a reservoir in the handpiece when the hand piece is docked in the base station. The liquid maythen be delivered through the mouthpiece during the cleaning process,and purged out of the system delivery and/or after the cleaning process.In another embodiment, the hand piece is connected to the base stationwith a liquid connection means, and liquid is delivered from a reservoirin the base station, through the hand piece, directly to the mouthpiece.

There may be consumable cartridges that may contain treatment solutions,cleaning solutions, diagnostic solutions, or similar. The cartridges maybe modular in design so as to be easily replaceable by the user.

The system may include a means of detecting the level of plaque on theteeth. One such method of detection is by coating the teeth with afluorescein solution, which has been proven to stick to plaque, andmonitoring the light waves emitted from the fluorescein-coated plaquevs. uncoated teeth regions. The light wave is different for each region,therefore it is discernable which areas and how much plaque exists onthe teeth. Other similar methods of plaque detection may also be used,such as vision systems.

Cleaning/Purging/Charging

The liquid system may be charged with disposable cartridges, refillingof a chamber, accessing a main reservoir in the base station withtubing, or other means of liquid transfer (gravimetric, hand pump,siphon pump, use of main pump drive or secondary system to fill/chargereservoirs, and similar). The liquid reservoirs may be filled with acombination of different liquids to create a unique combination ofdifferent liquid concentrations. In another embodiment, ingredients mayinitially be in a form other than liquid (gel, powder, tablet, andsimilar) and may be combined with liquid for added treatment and/orcleaning benefits.

The hand piece will have a purge setting that is simply and easilyactivated by the user during and/or after the cleaning process. This canbe accomplished with a method such as a single button pushed by the userthat will purge the hand piece of liquid and waste. In anotherembodiment, the excess liquid and waste is transferred from the handpiece to a waste reservoir or the sink drain, outside of or docked inthe base station. There may be a filtration system to protect thecomponents from contaminants. In a further embodiment, the hand piecehouses a disposable waste cartridge. In an alternate embodiment, themouthpiece is cleaned in the base station between uses. The cleaningmethod includes, but is not limited to, UV cleaning, alcohol bath,alternate cleaning liquid bath, or other similar method. The liquidcleaning bath may or may not circulate in and/or around the mouthpiece.

Drive System

The liquid system may be driven by a rotary motor with means totranslate motion from rotation to linear movement. This may be achievedvia eccentric cam, linear sliders, or other known methods. In analternate embodiment, a linear motor, or series of linear motors, maydrive the system. This would possibly reduce the size of the liquidsystem and gain additional control of liquid delivery through liquidvacuum. The motor(s) may directly drive the pistons up and down in atranslational fashion.

In order to optimize the design and minimize the size of the device, thecomponents of the linear drive may be integrated into the pump system.The piston itself may incorporate the magnet and the coil may beimbedded in or around the outer piston chamber walls. Alternatively thepiston and/or fixed attachment means to piston can be moving portion andthe magnet can be stationary (i.e. surrounding or within the pistonwalls). In addition, both the vacuum and delivery pistons may haveimbedded magnets that act against one another to create or assist withthe piston movement.

The motor will also drive the movement of the reciprocating flowcontroller. A rotary motor may have a worm, bevel, or similar gearassembly to translate the motor rotation to spin the reciprocating flowcontroller. The outer circumference of the reciprocating flow controllermay be comprised of gear teeth, which may be used as a means to rotatethe reciprocating flow controller disk from the translated motorrotation. Alternatively, a linear motor may drive the FDM in aratcheting fashion or geared fashion, such as motion transference likethe geneva mechanism.

In some embodiments, the pumping and vacuum sections may be orientedin-line with one another. Alternatively, they may be oriented parallelto each other. Each orientation has different advantages in regard tocompactness. The pumping and vacuum sections can be connected together,or alternatively operate independently, being synchronized in frequencyand/or some factor of frequency (i.e. vacuum section could have thevolumetric displacement of the delivery section, but move at a differentspeed) or could run asynchronously. If the delivery and vacuum sectionsare oriented in-line with one another, they may be connected to eachother via a rod. This may allow the delivery and vacuum pistons to bedriven simultaneously, ensuring synchronization between the pumping andvacuum strokes.

The delivery piston may be driven by the same rod that drives the vacuumpiston, but may have also some damping means and or delay one to theother, such as slot where it attaches to the piston. This may allow forextra play in the drive piston, causing the vacuum stroke to startslightly before the delivery stroke and continue slightly after thedelivery stroke. This may give the vacuum stroke additional opportunityto remove liquid from the appliance since it is still creating a vacuumwhile the delivery piston is dwelling, as well as minimizing leakage dueto gravity and appliance position into the oral cavity.

The vacuum piston and delivery piston may have means to dump liquid intoreservoir as a safety, in case either experiences any sort of partial orfull blockage, which could result in premature failure of devicecomponents (motors, valves, seals, etc). This allows for safe andcontrolled operation and prevents over pressurization when the main flowports are have been compromised and repeatable device performance forefficacy. By dumping into the local reservoir instead of to atmosphere,leakage potential outside of the device is minimized.

Temperature Control

In one embodiment, the liquid temperature may be controlled within aspecified range. If the liquid is too cold, it may cause discomfort andsensitivity in the user's mouth. If the liquid temperature is too high,it may cause discomfort, sensitivity, and damage to the user's mouth.The system may be confirmed not to run if the liquid temperature abovethe specified limit. A heating element may increase the temperature ifit is below the minimum specified limit. The system may be confirmed notto run unless the liquid temperature is within the specified range. Thetemperature feedback may be provided, but is not limited to thermistors,thermocouples, IR or other temperature monitoring means. Thisinformation may be fed back to the logic (AI) system.

The drive system may have means to heat the liquid to a specifictemperature range. Liquid may be heated in one or more locations of thesystem. Methods of heating the liquid include, but are not limited to,an inductive element, a radiant element, a ceramic element, a tubularsealed heating element (e.g. a fine coil of Nickel chrome wire in aninsulating binder (MgO, alumina powder), sealed inside a tube made ofstainless steel or brass), a silicone heater, a mica heater, or aninfrared heater.

An embodiment of a hand piece according to the present invention isshown in FIGS. 17a to 17e . FIG. 17a is an exploded view of a hand piece3000 that pumps liquid to, and pulls liquid from, the application tray,thus providing reciprocation of the liquid to and from the applicationtray. In this embodiment, hand piece 3000 is designed in a modularfashion, with a pumping section, a vacuum section, a reciprocatingsection, and pumping and driving sections. Modular construction allowsfor easier design for manufacturing (DFM), with easy assembly andrepair. The embodiment is also designed to minimize the size of thedevice as well as the amount of liquid used in operation.

Hand piece 3000 includes outlet pipes 3010 a and 3010 b, reciprocatingflow controller 710, inlet disk top section 3050, inlet disk bottomsection 3090, delivery cylinder sleeve 3110 with bubble-break plate 3115and delivery cylinder filling tube 3112, separator plates 3210, 3310,vacuum end disks 3250, 3290, vacuum piston 3270, vacuum cylinder sleeve3410, piston rod 3460, indexing shaft 3470, and diverter drive gear3472.

An exploded view of pumping section of hand piece 3000 is shown on FIG.17b . The figure shows outlet pipes 3010 attached to cap 720 ofreciprocating flow controller 710. Flow diverter disk 730, with positionadjuster 732 in the form of a gear, is disposed in cap 720 and sits onbase 740. O-ring 736 is between flow diverter disk 730 and base 740.Base ports 742 and 744 pass through base 740. Panel 735 for divertingliquid flow is disposed in flow diverter disk 730. Inlet disk topsection 3050 has inlet disk top section ports 3051, 3052, 3053, and3054, and is separated from base 740 by sealing gasket 3030. Inlet diskbottom section 3090 has inlet disk bottom section ports 3091, 3092,3095, 3096. Duel flap valve 3070 is between inlet disk top section 3050and inlet disk bottom section 3090, with the two flaps of duel flapvalve 3070 above inlet disk bottom section ports 3091 and 3092 and belowinlet disk top section ports 3052 and 3053. Inlet disk bottom sectionport 3091 includes a one-way valve 3093, allowing liquid to flow frominlet disk top section port 3052 to inlet disk bottom section port 3091through duel flap valve 3070. Inlet disk bottom section port 3092includes a one-way valve 3094, allowing liquid to flow from inlet diskbottom section port 3092 to inlet disk top section port 3053 throughduel flap valve 3070. Inlet disk bottom section 3090 is disposed on topof delivery cylinder sleeve 3110. Delivery is disposed along deliverycylinder sleeve 3110, while delivery piston 3130 is disposed in thevolume defined by delivery cylinder sleeve 3110. Bubble-break plate 3115is disposed about cylinder sleeve 3110. Delivery volume 3114 is thevolume defined by delivery cylinder sleeve 3110 minus the volume ofdelivery piston 3130.

FIG. 17c is an exploded view of vacuum section of hand piece 3000. Thefigure shows separator plate 3210, with separator plate ports 3212 and3214, disposed on top of vacuum end disk 3250. Vacuum end disk 3250 hasvacuum end disk ports 3251 and 3252. Flap valves 3230 a and 3230 b arebetween separator plate 3210 and vacuum end disks 3250. Flap valves 3230a and 3230 b are above vacuum end disk ports 3251 and 3252 and belowseparator plate ports 3212 and 3214. Vacuum end disk port 3251 includesa one-way valve 3253, allowing liquid to flow from vacuum end disk port3251 to separator plate port 3214 through flap valve 3230 a. Vacuum enddisk port 3252 includes a one-way valve 3254, allowing liquid to flowfrom separator plate port 3212 to vacuum end disk port 3251 through fromflap valve 3230 b. Vacuum piston 3270, disposed under vacuum end disks3250, has piston rod hole 3272 through which piston 3460 passes. Beneathvacuum piston 3270 is vacuum end disk 3290, disposed on top of separatorplate 3310. Vacuum end disk 3290 has vacuum end disk ports 3291 and3292. Separator plate 3310 has separator plate ports 3312 and 3314. Flapvalves 3230 c and 3230 d are between vacuum end disk 3290 and separatorplate 3310, above vacuum end disk ports 3291 and 3292 and belowseparator plate ports 3312 and 3314. Vacuum end disk port 3291 includesa one-way valve 3293, allowing liquid to flow from vacuum end disk ports3291 towards separator plate port 3314 through flap valve 3230 c. Vacuumend disk port 3292 includes a one-way valve 3294, allowing liquid toflow from separator plate port 3312 to vacuum end disk port 3292 throughflap valve 3230 d.

FIG. 17d is a side view of drive system of the pumping and drivingsections of hand piece 3000. Motor 3420 drives shaft 3422, which islinked to crankshaft arms 3430 a and 3430 b, and worm gear 3450.Crankshaft arms 3430 a and 3430 b are linked to crankshaft link arm3435, which is linked to piston rod 3460. Piston rod 3460 is attached tovacuum piston 3270 and, though not shown, delivery piston 3130. Indexingshaft 3470 is in contact with worm gear 3450, which is linked todiverter drive gear 3472. When shaft 3412 spins, crankshaft arms 3430 a,3430 b and crankshaft link arm 3435 convert the rotary motion of shaft3422 to a linear, reciprocating motion on piston rod 3460, such thatvacuum piston 3270 and delivery piston 3130 move up and down.Simultaneously, worm gear 3450 converts the rotary motion of shaft 3422to a rotary motion of indexing shaft 3470. Indexing shaft 3470 rotatesdiverter drive gear 3472, which is linked to position adjuster 732 inreciprocating flow controller 710.

FIG. 17e is a cut-away view of hand piece 3000, showing the spatialrelationships between the components in the pumping section, vacuumsection, and pumping and driving sections. Cylinder volume 3412 is thevolume of vacuum cylinder sleeve 3410 not occupied by the components ofthe pumping section, vacuum section, and pumping and driving sections,and serves as the liquid reservoir in the embodiment shown.

The general operation of hand piece 3000, is as follows:

-   -   1. Hand piece 3000 is sufficiently filled with cleaning liquid.        The liquid initially resides in cylinder volume 3412 of vacuum        cylinder sleeve 3410.    -   2. The user inserts any embodiment of an application tray, for        example application tray 100 or 1100, into their mouth. The hand        piece 3000 may be activated by a sensor (pressure sensor,        proximity sensor, etc.) or the device may be activated by the        user. The cleaning cycle is initiated.    -   3. On the “down stroke” of piston rod 3260, delivery piston 3130        pulls liquid from the bottom of cylinder volume 3412. The liquid        flows through delivery cylinder filling tube 3112, inlet disk        bottom section port 3095, inlet disk top section port 3051,        inlet disk top section port 3052, duel flap valve 3070, and        one-way valve 3093 in inlet disk bottom section port 3091, and        into delivery volume 3114. It is preferred that the entry port        3116 on delivery cylinder filling tube 3112 is located at the        bottom of the tube to minimize the total liquid required for        cleaning/treatment and to avoid pulling air into delivery volume        3114.    -   4. On the “upstroke” of piston rod 3260, delivery piston 3130        forces the liquid though inlet disk bottom section port 3092        with one-way valve 3094. The liquid flows through duel flap        valve 3070, through inlet disk top section port 3053, and        finally through base port 742 of reciprocating flow controller        710.    -   5. Liquid flow through reciprocating flow controller 710 is        described earlier using FIG. 4c and FIG. 4d . In brief, when        reciprocating flow controller 710 in its first position (FIG. 9c        ), incoming liquid from inlet disk top section port 3053 enters        reciprocating flow controller 710 through base port 742. The        liquid exits reciprocating flow controller 710 through cap port        722, flowing into outlet pipe 3010 b. Returning liquid, flowing        in through outlet pipe 3010 a, reenters reciprocating flow        controller 710 through cap port 724. The liquid exits        reciprocating flow controller 710 through base port 744. When        reciprocating flow controller 710 in its second position (FIG.        4d ), incoming liquid from inlet disk top section port 3053        enters reciprocating flow controller 710 through base port 742.        The liquid exits reciprocating flow controller 710 through cap        port 724, flowing into outlet pipe 3010 a. Returning liquid,        flowing in through outlet pipe 3010 b, reenters reciprocating        flow controller 710 through cap port 722. The liquid re-exits        reciprocating flow controller 710 through base port 744.        Reciprocation of cleaning liquid in application tray 100 of FIG.        1 is achieved by switching reciprocating flow controller 710        between its first and second positions. As shown in FIG. 17d ,        the switching of reciprocating flow controller 710 between its        first and second positions is achieved by worm gear 3450, which        converts the rotary motion of shaft 3422 to a rotary motion of        indexing shaft 3470. Indexing shaft 3470 rotates diverter drive        gear 3472, which is linked to position adjuster 732 in        reciprocating flow controller 710. Though shown as continually        rotating in this embodiment, it is to be understood that        reciprocating flow controller 710 may be driven via separate        means, such as another motor. Also, the time interval for        switching reciprocating flow controller 710 between its first        and second positions may, in some embodiments be between about 1        and about 100 seconds, or between about 2 and about 10 seconds,        and may be varied over the course of the cleaning/treatment.    -   6. In the present embodiment, the vacuum section of hand piece        3000 is effective during both the “upstroke” and “down stroke”        of piston rod 3260. Vacuum piston 3270 is dual acting, and draws        liquid from application tray 100 on both the upstroke and down        stroke of vacuum piston 3270. The liquid flowing through base        port 744 of reciprocating flow controller 710 flows through        inlet disk top section port 3054 and continues through inlet        disk bottom section port 3096, arriving in vacuum return tube        3412. The liquid in cylinder volume 3412 is then drawn to vacuum        volumes 3275 a or 3275 b. Vacuum volume 3275 a is the volume        between vacuum end disk 3250 and vacuum piston 3270. Vacuum        volume 3275 b is the volume between vacuum end disk 3290 and        vacuum piston 3270. During the “upstroke” of piston rod 3260,        the liquid in cylinder volume 3412 is drawn through separator        plate port 3312, and flows through flap valve 3230 d, one-way        valve 3294, and vacuum end disk port 3292, arriving in vacuum        volume 3275 b. During the “down stroke” of piston rod 3260, the        liquid in cylinder volume 3412 is drawn through separator plate        port 3212, and flows through flap valve 3230 b, one-way valve        3254, and vacuum end disk port 3222, arriving in vacuum volume        3275 a. As noted, the vacuum piston 3270 in this embodiment is        dual acting, drawing liquid from application tray 100 on both        the upstroke and down stroke of vacuum piston 3270. So, while        vacuum volume 3275 b is drawing in liquid from cylinder volume        3412, the liquid in vacuum volume 3275 a is being pumped into        cylinder volume 3412. In contrast, while vacuum volume 3275 a is        drawing in liquid from cylinder volume 3412, the liquid in        vacuum volume 3275 b is being pumped into cylinder volume 3412.        During the “upstroke” of piston rod 3260, the liquid in vacuum        volume 3275 a is pumped through vacuum end disk port 3251, and        flows through one-way valve 3253, flap valve 3230 a, and        separator plate port 3214, arriving in cylinder volume 3412.        During the “down stroke” of piston rod 3260, the liquid in        vacuum volume 3275 b is pumped through vacuum end disk port        3291, and flows through one-way valve 3293, flap valve 3230 c,        and separator plate port 3314, arriving in cylinder volume 3412.    -   7. The cycle continues with cycles comprising both “upstrokes”        and “down strokes” of piston rod 3260, with liquid motion        through hand piece 3000 as described in steps 3 through 6 above.

The ratio of the total volume of vacuum volumes 3275 a and 3275 b todelivery volume 3114 may be any range, such as 1:1, optionally about 3:1or greater, or about 4:1 or greater. Since delivery piston 3130 onlydelivers liquid on one “half” of the pumping/vacuuming cycle, whilevacuum piston 3270 works on both halves of the cycle, the ratio of thevolume of liquid delivered to application tray 100 to the volume ofliquid drawn from application tray 100 is 8:1 per cycle. The dual actingvacuum piston 3270 also provides vacuum during the half of the strokewhere delivery piston 3130 is not delivering liquid, increasing theopportunity to retrieve liquid from application tray 100, as well asclear additional liquid which leaked from application tray 100 into theoral cavity. Testing has shown a minimum 3:1 volumetric ratio of liquidvacuum to liquid delivery per stroke provided the necessary vacuum tominimize leakage into the oral cavity from application tray 100 when thetray has a marginal gingival seal, which may occur in embodiments of auniversal (designed to fit a range of people) application tray 100design.

In some embodiments vacuum piston 3270 is single acting. However, a dualacting vacuum piston 3270 may show some advantages.

In some embodiments, cylinder volume 3412 may have an air separator toreduce the foaming. Also, a breather vent may be required so that thepumping/vacuum system does not over pressurize and lock/fail. Thebreather vent may be on the opposite side of the cylinder volume 3412from the outlets of separator plate ports 3214 and 3314 to avoid liquidsplashing out of the breather vent. In addition there may be a wall tosplit the cylinder volume 3412 into two halves, to further reduce thechance of liquid splashing out of the breather vent.

In general, cylinder volume 3412 is vented since more liquid is beingdelivered to cylinder volume 3412 from the vacuum system than is beingdrawn from the delivery system. The excess (air) is exhausted from avent in cylinder volume 3412. The vent could use a valve, such as anumbrella valve, so air can escape but cannot enter the reservoir fromthe same opening, or a 2-way valve or vent hole. To further reduce lossof liquid through the vent, a wall may be used to divide cylinder volume3412 in two parts. One side contains the supply line, and the other sidecontains the vent. To optimize the separation of air from liquid incylinder volume 3412, an air separator may be placed in the reservoir,below the supply line. As the liquid drops from supply line intocylinder volume 3412, it passes through an air separator, which may be asolid plate with holes. This allows the liquid to pass, while removingentrained air and helping to separate the two liquid states (liquid vs.gas). The air separator may have various designs, such as an angledsolid shelf with holes, a spiraling ramp, a spiraling ramp with holes,two or more levels of angled shelves with holes, multiple spiralingramps, similar to a multiple starting points for threads, (bottle caps,etc), sporadically located bosses that the liquid hits as it drops,assisting in separation.

In one embodiment, the hand piece will be a self-contained, portableunit with a rechargeable battery, have a motor-driven piston pump forliquid delivery, have a mechanism to control the liquid flow, keep thetemperature within a specified range, be modular in design, and haveergonomics well-suited to the user's hand. When the hand piece is in thebase station, it will recharge the battery, refill the liquid reservoirsin the hand piece from those in the base station, and exchange samplesand/or diagnostic information with the base station. It may also gothrough a cleaning process.

FIGS. 18a-18l show an example of an embodiment of a dental cleaningsystem 2000 of the present invention. The figures show dental cleaningsystem 2000, showing hand piece 2220, base station 2250, and basestation liquid reservoir 2280. Base station liquid reservoir 2280 isused to refill the liquid reservoirs in hand piece 2220. Applicationtray 2100 is shown attached to hand piece 2220.

In this embodiment, base station filling tube 2245 is the conduitthrough which cleaning or treatment liquid passes from base stationliquid reservoir 2280 to the liquid reservoirs in hand piece 2220.Liquid leaves base station liquid reservoir 2280 through base stationliquid reservoir port 2285, and enters the liquid reservoirs in handpiece 2220 through hand piece port 2225.

When in base station 2250, the internal battery of hand piece 2220 willrecharge, and the liquid reservoirs in hand piece 2220 will refill fromthose in base station 2250. Any diagnostic information in hand piece2220 will be exchanged with base station 2250. Hand piece 2220 may alsogo through a cleaning process.

FIG. 18a is a front, top perspective view of an embodiment of a dentalcleaning system 2000, including hand piece 2220, base station 2250, andbase station liquid reservoir 2280. Base station 2250 includes basestation lid 2252, sanitation chamber 2254, UV sanitizing light 2256, UVlight kill switch 2206, start button 2262, indicator lights 2264, andpower cord with AC adapter 2270. UV sanitizing light 2256 in sanitationchamber 2254, is used to sanitize application tray 2100 between uses. UVlight kill switch 2206 shuts down UV sanitizing light 2256 when basestation lid 2252 is opened or ajar. The UV kill switch can also beutilized to initiate the sanitation process when the lid is closed andthe hand piece is docked. Indicator lights 2264 can be used to informthe user of the status of hand piece 2220 charge, position, orsanitation status, or the status of the base station liquid reservoir2280 (full/empty, for example).

Hand piece 2220 includes attached application tray 2100, and as shown inFIG. 18b , and hand piece port 2225. Fluid enters and exits hand piece2220 through hand piece port 2225.

A front, top perspective view of base station liquid reservoir 2280 isshown in FIG. 18c . As shown in the inset view of base station liquidreservoir 2280 (FIG. 18d ), base station liquid reservoir 2280 includesbase station liquid reservoir port 2285, from which fresh fluid is usedto fill hand piece 2220, and base station liquid reservoir lockingfeature 2282, used to engage base station liquid reservoir 2280 to basestation 2250. Base station liquid reservoir port 2285 includes O-ring2287 to insure a seal between reservoir port 2285 and base station inlettube 2245 a.

A partial cross-section of hand piece 2220 is shown in FIG. 18e . Asshown in the inset view of hand piece 2220 (FIG. 180, hand piece port2225 includes hand piece port 2225, from which fresh fluid is used tofill hand piece 2220. Hand piece port 2225 includes ball bearing 2222and spring 2224 assembly. Fluid entering hand piece 2220 through handpiece port 2225 passes through ball bearing 2222 and spring 2224assembly, which act as a sealing means for hand piece 2220, when notengaged in the base station.

FIG. 18g with inset view FIG. 18h shows the base station-to-hand piecedocking feature 2232. Fluid from base station port 2230 passes throughdocking feature 2232 prior to entering hand piece port 2225. O-ring 2234insures a seal between base station port 2230 and hand piece port 2225.A switch/sensor may also be located in the base station 2250 hand piecedocking area to ensure hand piece 2220 is in the proper docking positionfor fluid loading from base station 2250 and/or initiation of theappliance tray sanitation process. The hand held position/docking statusmay also be verified through feedback of the base station to hand heldcharging circuit.

FIG. 18i is a cut-away view of base station 2250 without hand piece 2220or base station liquid reservoir 2280 attached. The cut-away view showspump 2247, heating coil 2249, reservoir to pump tube 2245 a, basestation pump to base station port tube 2245 b, as well as themicrocontroller and circuit board 2241 and hand piece charging pad 2243located on base station 2250.

FIG. 18j is a cut-away view base station 2250 with base station liquidreservoir 2280 attached. Base station liquid reservoir locking feature2282 is used to engage base station liquid reservoir 2280 to basestation 2250. When engaged, fluid in base station liquid reservoir 2280can pass through base station reservoir tube 2282, exiting base stationliquid reservoir 2280 through reservoir port 2285 and entering basestation 2250 through base station inlet tube 2245 a. Heating coil 2249is used to warm fluid in tubes 2245 a and 2245 b prior to the fluidentering hand piece 2220.

FIG. 18k is a cut-away view of base station 2250 with hand piece 2220and base station liquid reservoir 2280 attached. As shown in inset view(FIG. 18l ), when hand piece 2220 is attached to base station 2250,docking feature 2232 contacts ball bearing 2222 and spring 2224assembly, displacing ball bearing 2222 and allowing fluid to fill handpiece 2220.

In this embodiment, base station liquid reservoir 2280 would be loadedin base station 2250, containing sufficient fluid quantity to allowreservoir 2280 to be used a number of times before being empty. Theremovable and replaceable reservoir 2280 would engage with the basestation 2250 through liquid reservoir locking feature 2282 to bothcorrectly position and hold reservoir 2280 in base station 2250, andprovide a seal for fluid conduit into the base station 2250.

Fluid would be pumped from base station liquid reservoir 2280 pastheating coil 2249 where it would be heated to an acceptable temperatureto minimize sensitivity when applied into the LCC when applied duringthe cleaning/treatment process.

Hand piece 2220 is placed into the handle dock in base station 2250 bythe user. Hand piece 2220 engages with base station 2250 through dockingfeatures to both correctly position and hold hand piece 2220 in thecorrect position in base station 2250 to allow fluid to be pumped frombase station liquid reservoir 2280 and into the local reservoir in handpiece 2220. Hand piece 2220 includes a feature that is opened to providethe conduit for fluid flow from base station 2250 when properly placedin the docking station. When hand piece 2220 is removed from basestation 2250, the fluid channel is automatically closed and sealed.

In summary, base station 2250 houses the handle fluid loading system,the fluid heating system, the mouthpiece UV sanitation chamber, thehandheld charging station, and control electronics and signalconditioning to control all aspects of the fluid loading, heating, andmouthpiece sanitation, as well as providing a docking station for thehand piece 2220 unit and the consumable reservoir 2280. Base station2250 may also include user interface to provide feedback to the user onthe system status and diagnostic analysis results such as, but notlimited to fluid level, charging level, sanitation process status, lasttime device was used.

In other embodiments, a piston pump with check-valves will be used forliquid delivery.

In yet other embodiments, a rotary piston pump will be used for liquiddelivery. This pump is known by those in the art, and the piston rotatesas it reciprocates, therefore not needing any valves to operate.Reversing the rotation direction of the drive motor will reverse theliquid flow direction.

In still other embodiments diaphragm pumps, gear pumps, or double-actionpiston pumps will be used for liquid delivery. In the case ofdouble-action piston pumps, when the liquid system is charged, this pumptype has the benefit of reciprocating the direction of the liquid flowto the mouthpiece. Charged pneumatic cylinders, hand pump, or rotarypumps may be used to drive the system.

Example

A test was performed in which 4 subjects used devices according to thepresent invention to assess efficacy of the devices and methods of theinvention from a germ removal and kill perspective. One of the endpointmethods used included bacterial viability determination via adenosinetriphosphate (ATP) luminescence and total plate counts. Appropriatedilutions of the baseline samples were made in 0.1% peptone water. Boththe rinsate and post-rinse samples were neutralized to stopantimicrobial actions and were diluted PO₄ neutralizer. Mouthpiecessubstantially similar to those depicted in FIGS. 16-19 (universalmouthpiece) and FIGS. 20-23 (custom-fit) were used in the test, one eachof which was tested using water and the other with Cool Mint Listerine®mouth rinse (CML).

Total Cell Counts measuring colony forming units (CFU/ml), includingtotal viable bacterial cells and total viable bad breath organisms, wereused, respectively. The samples taken from the subjects were incubatedunder anaerobic conditions for 5 days at 35-37° C. The Relative LightUnits (RLU) is a measure of the amount of ATP in a sample. The higherthe RLU value, the more ATP is present, and the more live bacteria thereare. Total cell counts (CFU/ml) and RLU were determined for each sampletaken from the subjects both before (baseline) and post rinsing, as wellas on rinsates collected after rinsing.

The subjects rinsed the oral cavity with 5 mL water for 10 seconds. Thebaseline example was collected by having the subject expectorate therinse water into a conical tube, and then expectorating an additional 1ml of saliva into that tube. Each subject then rinsed the oral cavity, 2with water using the respective mouthpiece designs, and 2 with the CoolMint Listerine using the respective mouthpiece designs. The rinsate wasthen collected for each subject and 20 mL was placed in a conical tube.Each subject then repeated the rinse with 5 mL of water for 10 secondsand, as before, the rinse and the post-rinse sample collected in aconical tube. The samples were neutralized, diluted, plated and thenincubated for 5 days and the cell counts and ATP measured. Results arepresented in Tables 1-3. Subject 1 BL used water as the liquid and theuniversal mouthpiece. Subject 2 BL used water as the liquid and thecustom-fit mouthpiece. Subject 3 BL used CML as the liquid and theuniversal mouthpiece. Subject 4 BL used CML as the liquid and thecustom-fit mouthpiece.

TABLE 1 % Reduction Total Organisms Average Counts from baseline logreduction Subject 1 BL 1.88E+07 Subject 2 BL 2.07E+07 Subject 3 BL1.13E+08 Subject 4 BL 1.93E+08 Subject 1 Rinsate 7.40E+04 99.6% 2.40Subject 2 Rinsate 1.90E+04 99.9% 3.04 Subject 3 Rinsate 2.00E+03 100.0%4.75 Subject 4 Rinsate 3.00E+03 100.0% 4.81 Subject 1 Post 7.50E+0596.0% 1.40 Subject 2 Post 3.02E+06 85.4% 0.84 Subject 3 Post 8.70E+0692.3% 1.11 Subject 4 Post 7.20E+06 96.3% 1.43

TABLE 2 % Reduction Bad Breath Organisms Average Counts from baselinelog reduction Subject 1 BL 5.30E+06 Subject 2 BL 2.70E+06 Subject 3 BL2.10E+07 Subject 4 BL 3.50E+07 Subject 1 Rinsate 3.10E+04 99.4% 2.23Subject 2 Rinsate 1.00E+03 100.0% 3.43 Subject 3 Rinsate 1.50E+03 100.0%4.15 Subject 4 Rinsate 1.00E+03 100.0% 4.54 Subject 1 Post 6.50E+0587.7% 0.91 Subject 2 Post 4.40E+05 83.7% 0.79 Subject 3 Post 2.80E+0686.7% 0.88 Subject 4 Post 2.10E+06 94.0% 1.22

TABLE 3 ATP RLU % Reduction from baseline log reduction Subject 1 BL7.44E+04 Subject 2 BL 3.93E+04 Subject 3 BL 2.18E+05 Subject 4 BL3.12E+05 Subject 1 Rinsate 3.14E+04 57.7% 0.37 Subject 2 Rinsate2.85E+04 27.4% 0.14 Subject 3 Rinsate 2.81E+04 87.1% 0.89 Subject 4Rinsate 2.61E+04 91.6% 1.08 Subject 1 Post 3.01E+04 59.5% 0.39 Subject 2Post 2.90E+04 26.1% 0.13 Subject 3 Post 7.04E+04 67.7% 0.49 Subject 4Post 3.40E+04 89.1% 0.96

CONCLUSIONS

Post-rinse plate count data demonstrates approximate significantreduction for both water rinse and CML rinse. Analysis of the rinsateplate count data also demonstrates a significant reduction from thebaseline in the water rinse, and even more significant reduction fromthe baseline in the CML rinse. The log reductions present in the waterrinsate suggests mechanical bacterial removal during treatment in theabsence of antimicrobials. The higher log reductions present in the CMLrinsate suggests a combination of mechanical and antimicrobial activityduring treatment.

Though several embodiments have been described, it should be understoodthat the scope of the present invention embraces other possiblevariations, being limited only by the contents of the accompanyingclaims, which includes the possible equivalents.

What is claimed is:
 1. A device suitable for collecting sample of afluid from the oral cavity of a mammal, comprising: a mouthpiececomprising a chamber defined by front and rear inner walls and a baseinner wall of said mouthpiece, said base wall extending between saidfront and rear inner walls, each of said front and rear inner walls ofsaid chamber comprising a plurality of openings, said mouthpiece furthercomprising a first manifold for containing a first portion of a liquidand providing said first portion to said chamber through said openingsof said front inner wall, a second manifold for containing a secondportion of said liquid and providing said second portion to said chamberthrough said openings of said rear inner wall, and a first port forconveying said first portion of said liquid to and from said firstmanifold, a second port for conveying said second portion of said liquidto and from said second manifold; means for providing reciprocationcomprising a pump system for alternately: (i) directing fluid into saidchamber through said first manifold and out of said chamber through saidsecond manifold, and (ii) directing fluid into said chamber through saidsecond manifold and out of said chamber through said first manifold; andmeans for collecting said fluid sample from said oral cavity.
 2. Thedevice of claim 1 wherein said fluid is selected from the groupconsisting of a gas, gingival crevicular fluid, blood and saliva.
 3. Thedevice of claim 1 wherein said means for collecting said fluid sample isselected from the group consisting of a manifold dedicated to collectionof said fluid, an orifice and a plurality of nozzles placed at spacedintervals about said mouthpiece.
 4. The device of claim 1 wherein saidmeans for collecting fluid samples comprise said openings in at leastone of said inner walls, at least one of said first and second manifoldsand at least one of said first and second ports.
 5. The device of claim1 comprising a compartment for storage of said fluid sample.
 6. Thedevice of claim 5 wherein said compartment is detachable from saiddevice.
 7. A method for collecting and analyzing a sample of a fluidfrom the oral cavity of a mammal, said method comprising: placing adevice suitable for collecting said sample of said fluid in said oralcavity of said mammal, said device comprising: a mouthpiece comprising achamber defined by front and rear inner walls and a base inner wall ofsaid mouthpiece, said base wall extending between said front and rearinner walls a mouthpiece comprising a chamber defined by front and rearinner walls and a base inner wall of said mouthpiece, said base wallextending between said front and rear inner walls, each of said frontand rear inner walls of said chamber comprising a plurality of openings,said mouthpiece further comprising a first manifold for containing afirst portion of a liquid and providing said first portion to saidchamber through said openings of said front inner wall, a secondmanifold for containing a second portion of said liquid and providingsaid second portion to said chamber through said openings of said rearinner wall, and a first port for conveying said first portion of saidliquid to and from said first manifold, a second port for conveying saidsecond portion of said liquid to and from said second manifold; meansfor providing reciprocation comprising a pump system for alternately:(i) directing fluid into said chamber through said first manifold andout of said chamber through said second manifold, and (ii) directingfluid into said chamber through said second manifold and out of saidchamber through said first manifold; and means for collecting said fluidsample from said oral cavity, collecting said fluid sample from saidoral cavity; and conducting an analysis of said fluid sample.
 8. Themethod of claim 7 wherein said collection is conducted simultaneouslywith directing said liquid onto said plurality of surfaces of said oralcavity of said mammal.
 9. The method of claim 7 wherein said collectionis conducted prior to directing said liquid onto said plurality ofsurfaces of said oral cavity of said mammal.
 10. The method of claim 7wherein said collection is conducted after directing said liquid ontosaid plurality of surfaces of said oral cavity of said mammal.
 11. Themethod of claim 7 wherein said collection is conducted prior to andafter directing said liquid onto said plurality of surfaces of said oralcavity of said mammal.
 12. The method of claim 7 wherein said collectionis conducted prior to, simultaneously with and after directing saidliquid onto said plurality of surfaces of said oral cavity of saidmammal.
 13. The method of claim 7 wherein analysis of said fluid sampleis conducted by a method selected from the group consisting of lateralflow technology, microfluidic immunoassay, DNA-DNA hybridization, colormetrics, photoimaging, gas chromatography, zinc oxide semiconductorsensors, quantitative light fluorescence and quantitative PolymeraseChain Reaction.
 14. The method of claim 7 wherein said means forcollecting said fluid sample is selected from the group consisting of amanifold dedicated to collection of said fluid, an orifice and aplurality of nozzles placed at spaced intervals about said mouthpiece,said openings in at least one of said inner walls, at least one of saidfirst and second manifolds and at least one of said first and secondports.
 15. The method of claim 7 wherein said means for collecting saidfluid sample is selected from the group consisting of said openings inat least one of said inner walls, at least one of said first and secondmanifolds and at least one of said first and second ports.
 16. Themethod of claim 7 wherein said fluid is selected from the groupconsisting of a gas, gingival crevicular fluid, blood and saliva. 17.The method of claim 7 further comprising introducing an agent selectedfrom the group consisting of a fluid sample stimulating agent, aconglomeration agent and a coagulation agent.